ISO/TS 19844:2018
Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances
This document is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.
ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high-level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances.
This third edition of the document addresses Substances Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G, H, I, J and K. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 is covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, might be essential to distinguishing substances. This document addresses the following:
- data elements necessary for defining Substances and Specified Substances Groups 1 to 3;
- the logical use of data elements as defined in ISO 11238;
- Substances and Specified Substances Groups 1 to 3 business rules for:
- - determining necessary data elements,
- - distinguishing and defining materials according to ISO 11238,
- - triggering the assignment of identifiers.
This document does not address the following:
- business processes for data management;
- implementation of a specific data information system (e.g. a relational database schema);
- normative messaging standards for substances;
- the maintenance of controlled vocabularies;
- the specific global identifier system that should be used;
- nomenclature standards for substances.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General background and history
6 Substance (Mandatory)
6.1 General
6.2 Defining substances
6.2.1 Substance type (Mandatory)
6.2.2 Substance ID (Mandatory)
6.3 Substance names (Mandatory)
6.3.1 Substance name (Mandatory)
When requesting an ID, a submitter should submit all names and company codes which have been associated with the substance. A submitter may also want to add a name to a substance that is already in the database. Defining information for a given substance should also be transmitted when requesting that a name is added to the database to ensure the correct substance identity. A submitter may also submit names in multiple languages. Although there is no requirement that names are unique, other or common names should also explicitly distinguish related substances from one another. Distinguishing characteristics for many polymers, such as molecular weight, degree of polymerization, and viscosity, should be indicated in the names of these substances. Standardization on such names to facilitate searching and identification of substances may be adopted within regions.
6.3.2 Substance name type (Mandatory)
6.3.3 Language (Mandatory)
6.3.4 Substance name domain (Conditional)
6.3.5 Jurisdiction (Conditional)
6.3.6 Official name (Conditional)
6.3.6.1 Official name type (Mandatory)
6.3.6.2 Official name status (Conditional)
6.3.6.3 Official name status change date (Conditional)
6.4 Reference source (Conditional)
6.4.1 Public domain (Conditional)
6.4.2 Reference source type (Mandatory)
6.4.3 Reference source class (Optional)
6.4.4 Reference source ID (Conditional)
6.4.5 Reference source citation (Conditional)
6.4.6 Reference source URL (Conditional)
6.4.7 Reference source document (Conditional)
6.4.7.1 Public domain (Conditional)
6.4.7.2 Reference source document (Optional)
6.4.7.3 Reference source document type (Optional)
6.4.7.4 Reference source document ID (Optional)
6.4.7.5 Reference source document classification (Optional)
6.5 Substance code (Conditional)
6.5.1 Code (Mandatory)
6.5.2 Code system (Mandatory)
6.5.3 Code system ID (Mandatory)
6.5.4 Code system status (Mandatory)
6.5.5 Code change date (Optional)
6.5.6 Comment (Optional)
6.5.7 Reference source (Conditional)
6.5.7.1 Reference source document (Conditional)
6.6 Reference information (Conditional)
6.6.1 Comment (Optional)
6.6.2 Substance classification (Conditional)
6.6.2.1 Domain (Optional)
6.6.2.2 Substance classification (Optional)
6.6.2.3 Substance classification code (Optional)
6.6.2.4 Substance classification type (Optional)
6.6.2.5 Substance classification subtype (Optional)
6.6.2.5.1 Substance class subtype (Optional)
6.6.2.6 Reference source (Conditional)
6.6.3 Substance relationship (Conditional)
6.6.3.1 Related substance ID (Conditional)
6.6.3.2 Related substance name (Conditional)
6.6.3.3 Relationship (Conditional)
6.6.3.4 Relationship type (Optional)
6.6.3.5 Is Defining (Mandatory)
6.6.3.6 Amount (Conditional)
6.6.3.6.1 Reference range (Conditional)
6.6.3.7 Reference source (Optional)
6.6.3.7.1 Reference source document (Optional)
6.6.4 Target (Conditional)
6.6.4.1 Target ID (Conditional)
6.6.4.2 Target name (Conditional)
6.6.4.3 Interaction type (Conditional)
6.6.4.4 Target organism (Conditional)
6.6.4.5 Target organism type (Conditional)
6.6.4.6 Target type (Optional)
6.6.4.7 Amount (Conditional)
6.6.4.7.1 Reference range (Conditional)
6.6.4.8 Reference source (Optional)
6.6.4.8.1 Reference source document (Optional)
6.6.5 Gene (Conditional)
6.6.5.1 Gene sequence origin (Conditional)
6.6.5.2 Gene ID (Conditional)
6.6.5.3 Gene name (Conditional)
6.6.5.4 Reference source (Conditional)
6.6.5.4.1 Reference source document (Optional)
6.6.6 Gene element (Conditional)
6.6.6.1 Gene element type (Conditional)
6.6.6.2 Gene element ID (Conditional)
6.6.6.3 Gene element name (Conditional)
6.6.6.4 Reference source (Conditional)
6.6.6.4.1 Reference source document (Optional)
6.7 Structure (Conditional)
6.7.1 Stereochemistry (Conditional)
6.7.2 Optical activity (Conditional)
6.7.3 Molecular Formula (Conditional)
6.7.4 Molecular Formula by Moiety (Conditional)
6.7.5 Molecular weight (Mandatory)
6.7.6 Structural Representation (Conditional)
6.7.6.1 Structural representation type (Conditional)
6.7.6.2 Structural representation (Conditional)
6.7.6.3 Structural representation attachment (Optional)
6.7.7 Isotope (Conditional)
6.7.7.1 Nuclide ID (Conditional)
6.7.7.2 Nuclide name (Conditional)
6.7.7.3 Substitution type (Conditional)
6.7.7.4 Nuclide Half Life (Optional)
6.7.7.5 Amount (Conditional)
6.7.7.5.1 Reference range (Conditional)
6.7.7.6 Molecular weight (Mandatory)
6.7.8 Reference Source (Conditional)
6.7.8.1 Reference source document (Conditional)
6.8 Amount (Conditional)
6.8.1 Amount type (Conditional)
6.8.2 Quantity (Conditional)
6.8.3 Low limit (Conditional)
6.8.4 High limit (Conditional)
6.8.5 Unit (Conditional)
6.8.6 Non-numeric Value (Conditional)
6.8.7 Amount text (Conditional)
6.8.8 Reference range (Conditional)
6.8.8.1 Low limit (Conditional)
6.8.8.2 High limit (Conditional)
6.8.8.3 Unit (Conditional)
6.9 Source material (Conditional)
6.9.1 Source material class (Conditional)
6.9.2 Source material type (Conditional)
6.9.3 Source material state (Conditional)
6.9.4 Organism ID (Conditional)
6.9.5 Organism name (Conditional)
6.9.6 Parent substance ID (Conditional)
6.9.7 Parent substance name (Conditional)
6.9.8 Country of origin (Conditional)
6.9.9 Geographical location (Conditional)
6.9.10 Development stage (Conditional)
6.9.11 Part Description (Conditional)
6.9.11.1 Part (Mandatory)
6.9.11.2 Part location (Conditional)
6.9.11.3 Reference source (Conditional)
6.9.11.3.1 Reference source document (Conditional)
6.9.12 Fraction description (Conditional)
6.9.12.1 Fraction (Conditional)
6.9.12.2 Material type (Conditional)
6.9.12.3 Reference Source (Conditional)
6.9.12.3.1 Reference source document (Conditional)
6.9.13 Organism (Conditional)
6.9.13.1 Family (Conditional)
6.9.13.2 Genus (Conditional)
6.9.13.3 Species (Conditional)
6.9.13.4 Intraspecific type (Optional)
6.9.13.5 Intraspecific description (Conditional)
6.9.13.6 Author (Conditional)
6.9.13.6.1 Author type (Conditional)
6.9.13.6.2 Author description (Conditional)
6.9.13.7 Organism general (Conditional)
6.9.13.7.1 Kingdom (Conditional)
6.9.13.7.2 Phylum (Conditional)
6.9.13.7.3 Class (Conditional)
6.9.13.7.4 Order (Conditional)
6.9.13.8 Hybrid (Conditional)
6.9.13.8.1 Hybrid species maternal organism ID (Optional)
6.9.13.8.2 Hybrid species maternal organism name (Optional)
6.9.13.8.3 Hybrid species paternal organism ID (Optional)
6.9.13.8.4 Hybrid species paternal organism name (Optional)
6.9.13.8.5 Hybrid type (Conditional)
6.10 Modification (Conditional)
6.10.1 Modification type (Conditional)
6.10.2 Residue modified (Conditional)
6.10.3 Residue site (Conditional)
6.10.4 Structural modification (Conditional)
6.10.4.1 Structural modification type (Conditional)
6.10.4.2 Moiety (Conditional)
6.10.4.2.1 Amount (Conditional)
6.10.4.2.1.1 Reference range (Conditional)
6.10.4.3 Molecular fragment (Conditional)
6.10.4.3.1 Molecular fragment role (Conditional)
6.10.4.3.2 Molecular fragment ID (Mandatory)
6.10.4.3.3 Molecular fragment name (Mandatory)
6.10.4.3.4 Amount (Conditional)
6.10.4.3.5 Structure (Conditional)
6.10.5 Agent modification (Conditional)
6.10.5.1 Agent modification type (Mandatory)
6.10.5.2 Role (Mandatory)
6.10.5.3 Modification agent ID (Conditional)
6.10.5.4 Modification agent (Conditional)
6.10.5.5 Modification process (Conditional)
6.10.5.6 Amount (Conditional)
6.10.5.6.1 Reference range (Conditional)
6.10.6 Physical Modification (Conditional)
6.10.6.1 Role (Mandatory)
6.10.6.2 Number of parameters (Conditional)
6.10.6.3 Parameters (Conditional)
6.10.6.3.1 Parameter (Mandatory)
6.10.6.3.2 Amount (Mandatory)
6.10.6.3.2.1 Reference range (Conditional)
6.11 Property (Conditional)
6.11.1 Property type (Conditional)
6.11.2 Property name (Conditional)
6.11.3 Property parameters (Conditional)
6.11.4 Property substance ID (Conditional)
6.11.5 Property substance name (Conditional)
6.11.6 Amount (Mandatory)
6.11.6.1 Reference range (Conditional)
6.12 Version (Mandatory)
6.12.1 Version number (Mandatory)
6.12.2 Effective date (Mandatory)
6.12.3 Change made (Conditional)
7 Substance definitions
7.1 Chemical substance
7.1.1 Structure (Mandatory)
7.1.2 Stoichiometric/Non-stoichiometric chemicals
7.1.2.1 Stoichiometric chemicals
7.1.2.2 Non-stoichiometric
7.1.3 Stoichiometric (Mandatory)
7.1.4 Number of moieties (Conditional)
7.1.5 Comment (Optional)
7.1.6 Moiety (Conditional)
7.1.6.1 Moiety role (Conditional)
7.1.6.2 Moiety ID (Mandatory)
7.1.6.3 Moiety name (Mandatory)
7.1.6.4 Stereochemistry (Conditional)
7.1.6.5 Optical activity (Conditional)
7.1.6.6 Molecular formula (Conditional)
7.1.6.7 Molecular formula by moiety (Conditional)
7.1.6.8 Amount (Conditional)
7.1.6.8.1 Reference range (Conditional)
7.1.7 Property (Conditional)
7.1.7.1 Amount (Mandatory)
7.1.7.1.1 Reference range (Conditional)
7.1.8 Substance Name (Mandatory)
7.1.9 Substance Code (Conditional)
7.1.10 Version (Mandatory)
7.1.11 Reference information (Conditional)
7.1.12 Reference source (Conditional)
7.1.12.1 Reference source document (Conditional)
7.2 Proteins/peptides
7.2.1 Microheterogeneity
7.2.2 Sequence type (Mandatory)
7.2.3 Number of subunits (Mandatory)
7.2.4 Disulfide linkage (Conditional)
7.2.5 Comment (Optional)
7.2.6 Protein subunit (Mandatory)
7.2.6.1 Subunit (Mandatory)
7.2.6.2 Sequence (Mandatory)
7.2.6.3 Length (Mandatory)
7.2.6.4 Sequence attachment (Conditional)
7.2.6.5 N_Terminal modification ID (Conditional)
7.2.6.6 N_Terminal modification (Conditional)
7.2.6.7 C_Terminal modification ID (Conditional)
7.2.6.8 C_Terminal modification (Conditional)
7.2.7 Molecular weight (Conditional)
7.2.7.1 Molecular weight method (Mandatory)
7.2.7.2 Molecular weight type (Conditional)
7.2.7.3 Amount (Mandatory)
7.2.7.3.1 Reference range (Conditional)
7.2.8 Glycosylation (Conditional)
7.2.8.1 Glycosylation type (Conditional)
7.2.8.2 N_Glycosylation site (Conditional)
7.2.8.3 O-Glycosylation site (Conditional)
7.2.8.4 C-Glycosylation site (Conditional)
7.2.9 Property (Conditional)
7.2.9.1 Amount (Mandatory)
7.2.9.1.1 Reference range (Conditional)
7.2.10 Structure (Conditional)
7.2.11 Substance name (Mandatory)
7.2.12 Modification (Conditional)
7.2.13 Substance code (Conditional)
7.2.14 Source material (Conditional)
7.2.15 Version (Mandatory)
7.2.16 Reference information (Conditional)
7.2.17 Reference source (Conditional)
7.2.17.1 Reference source document (Conditional)
7.3 Nucleic acids
7.3.1 Structure (Conditional)
7.3.2 Sequence type (Mandatory)
7.3.3 Number of subunits (Mandatory)
7.3.4 Area of hybridization (Conditional)
7.3.5 Oligo nucleotide type (Conditional)
7.3.6 Comment (Optional)
7.3.7 Nucleic acid subunit (Mandatory)
7.3.7.1 Subunit (Mandatory)
7.3.7.2 Sequence (Mandatory)
7.3.7.3 Length (Mandatory)
7.3.7.4 Sequence attachment (Conditional)
7.3.7.5 Five prime ID (Conditional)
7.3.7.6 Five prime (Conditional)
7.3.7.7 Three prime ID (Conditional)
7.3.7.8 Three prime (Conditional)
7.3.7.9 Sugar (Conditional)
7.3.7.9.1 Sugar ID (Mandatory)
7.3.7.9.2 Sugar name (Mandatory)
7.3.7.9.3 Residue site (Mandatory)
7.3.7.10 Linkage (Conditional)
7.3.7.10.1 Linkage connectivity (Conditional)
7.3.7.10.2 Linkage ID (Conditional)
7.3.7.10.3 Linkage name (Conditional)
7.3.7.10.4 Residue site (Mandatory)
7.3.7.11 Reference source (Conditional)
7.3.7.11.1 Reference source document (Conditional)
7.3.8 Modification (Conditional)
7.3.9 Property (Conditional)
7.3.9.1 Amount (Mandatory)
7.3.9.1.1 Reference range (Conditional)
7.3.10 Molecular weight (Conditional)
7.3.10.1 Amount (Mandatory)
7.3.10.1.1 Reference range (Conditional)
7.3.11 Substance Name (Mandatory)
7.3.12 Substance Code (Conditional)
7.3.13 Version (Mandatory)
7.3.14 Reference information (Conditional)
7.3.15 Reference source (Conditional)
7.3.15.1 Reference source document (Conditional)
7.4 Polymers
7.4.1 Polymer class (Mandatory)
7.4.2 Polymer geometry (Mandatory)
7.4.3 Copolymer connectivity (Mandatory)
7.4.4 Comment (Optional)
7.4.5 Substance name (Mandatory)
7.4.6 Structure (Mandatory)
7.4.7 Monomer set description (Conditional)
7.4.7.1 Number of monomers (Mandatory)
7.4.7.2 Monomer amount type (Conditional)
7.4.7.3 Polymer Starting material (Conditional)
7.4.7.3.1 Starting material ID (Mandatory)
7.4.7.3.2 Starting material name (Mandatory)
7.4.7.3.3 Starting material type (Mandatory)
7.4.7.3.4 Is defining (Mandatory)
7.4.7.3.5 Amount (Conditional)
7.4.7.3.5.1 Reference range (Conditional)
7.4.8 Structural repeat (Mandatory)
7.4.8.1 Number of structural repeat units (Mandatory)
7.4.8.2 Average molecular formula by repeat unit (Conditional)
7.4.8.3 Structural repeat unit amount type (Conditional)
7.4.8.4 Structural repeat unit (Mandatory)
7.4.8.4.1 Orientation of polymerization (Mandatory)
7.4.8.4.2 Structural repeat unit (Mandatory)
7.4.8.4.3 Amount (Mandatory)
7.4.8.4.3.1 Reference range (Conditional)
7.4.8.4.4 Structural representation (Mandatory)
7.4.8.4.5 Degree of polymerization (Conditional)
7.4.8.4.5.1 Degree of polymerization (Mandatory)
7.4.8.4.5.2 Amount (Mandatory)
7.4.8.4.5.2.1 6.4.8.4.5.2.1 Reference range (Conditional)
7.4.9 Molecular weight (Conditional)
7.4.9.1 Amount (Mandatory)
7.4.9.1.1 Reference range (Conditional)
7.4.10 Property (Conditional)
7.4.10.1 Amount (Mandatory)
7.4.10.1.1 Reference range (Conditional)
7.4.11 Substance code (Conditional)
7.4.12 Version (Mandatory)
7.4.13 Reference information (Conditional)
7.4.14 Modification (Conditional)
7.4.15 Source material (Conditional)
7.4.16 Reference source (Conditional)
7.4.16.1.1 Reference source document (Conditional)
7.5 Structurally diverse substances
7.5.1 Comment (Optional)
7.5.2 Substance name (Mandatory)
7.5.3 Structure (Conditional)
7.5.4 Property (Conditional)
7.5.4.1 Amount (Mandatory)
7.5.4.1.1 Reference range (Conditional)
7.5.5 Molecular weight (Conditional)
7.5.5.1 Amount (Mandatory)
7.5.5.1.1 Reference range (Conditional)
7.5.6 SD glycosylation (Conditional)
7.5.6.1 SD glycosylation type (Conditional)
7.5.7 Modification (Conditional)
7.5.8 Source material (Mandatory)
7.5.9 Substance code (Conditional)
7.5.10 Reference information (Conditional)
7.5.11 Version (Mandatory)
7.5.12 Reference source (Conditional)
7.5.12.1 Reference source document (Conditional)
7.5.13 Herbals and substances used in the preparation of plant-based allergenic extracts
7.5.13.1 Naming vegetable oils
7.5.13.1.1 Example: Olive Oil, Virgin
7.5.14 Vaccines
7.5.15 Plasma-derived substance for human blood products and polyclonal antibodies
7.5.16 Allergens
7.5.17 Advanced Therapies and Advanced Vaccines (Genes, Modified Viruses, Cells and Tissues as Substances)
7.5.18 Minerals
7.6 Mixture
7.6.1 Mixture type (Mandatory)
7.6.2 Is multi-substance starting material (Mandatory)
7.6.3 Constituent component (Mandatory)
7.6.3.1 Constituent component ID (Mandatory)
7.6.3.2 Constituent component name (Mandatory)
7.6.3.3 Constituent component requirement (Mandatory)
7.6.3.4 Constituent component role (Conditional)
7.6.3.5 Amount (Conditional)
7.6.4 Multi-substance starting material property (Conditional)
7.6.4.1 Multi-substance property type (Conditional)
7.6.4.2 Multi-substance property name (Conditional)
7.6.4.3 Multi-substance property parameter (Conditional)
7.6.5 Modification (Conditional)
7.6.6 Source material (Conditional)
7.6.7 Substance name (Mandatory)
7.6.8 Substance code (Conditional)
7.6.9 Reference information (Conditional)
7.6.10 Version (Mandatory)
8 Specified substance (Conditional)
8.1 Specified Substance Group 1 (Conditional)
8.1.1 Specified substance Group 1 ID (Mandatory)
8.1.2 Substance name (Mandatory)
8.1.3 Substance Code (Conditional)
8.1.4 Version (Mandatory)
8.1.5 Reference source (Conditional)
8.1.5.1 Reference source document (Conditional)
8.1.6 Constituent (Conditional)
8.1.6.1 Constituent substance ID (Mandatory)
8.1.6.2 Contituent substance name (Mandatory)
8.1.6.3 Language (Conditional)
8.1.6.4 Substance role (Mandatory)
8.1.6.5 Is defining (Mandatory)
8.1.6.6 Amount (Conditional)
8.1.6.6.1 Reference range (Conditional)
8.1.7 Characteristic attribute (Conditional)
8.1.7.1 Attribute type (Mandatory)
8.1.7.2 Attribute name (Mandatory)
8.1.7.3 Attribute substance ID (Conditional)
8.1.7.4 Attribute substance name (Conditional)
8.1.7.5 Is defining (Mandatory)
8.1.7.6 Amount (Mandatory)
8.1.7.6.1 Reference range (Conditional)
8.1.7.7 Attribute parameter (Conditional)
8.1.7.7.1 Attribute parameter name (Mandatory)
8.1.7.7.2 Attribute parameter value (Mandantory)
8.1.7.7.3 Amount (Mandatory)
8.1.7.7.3.1 Reference range (Conditional)
8.1.8 Fraction description (Conditional)
8.1.8.1 Fraction (Conditional)
8.1.8.2 Material type (Conditional)
8.1.8.3 Reference Source (Conditional)
8.1.8.3.1 Reference source document (Conditional)
8.1.9 Modification (Conditional)
8.1.10 Reference Information (Conditional)
8.1.11 Physical form (Conditional)
8.1.11.1 Physical state (Mandatory)
8.1.11.2 Physical form type (Conditional)
8.1.11.3 Amount (Conditional)
8.1.11.3.1 Reference range (Conditional)
8.2 Specified substance Group 2 (Conditional)
8.2.1 Specified Substance Group 2 ID (Mandatory)
8.2.2 Substance Name (Mandatory)
8.2.3 Substance code (Conditional)
8.2.4 Reference source (Conditional)
8.2.4.1 Reference source document (Conditional)
8.2.5 Reference information (Conditional)
8.2.6 Version (Mandatory)
8.2.7 Manufacturing (Mandatory)
8.2.7.1 Manufacturing type (Conditional)
8.2.7.2 Production method type (Conditional)
8.2.7.3 Production method description (Conditional)
8.2.7.4 Production system type (Conditional)
8.2.7.5 Production system (Conditional)
8.2.7.6 Critical process version number (Conditional)
8.2.7.7 Version (Mandatory)
8.2.7.8 Version date (Mandatory)
8.2.7.9 Organization (Mandatory)
8.2.7.9.1 Manufacturer ID (Mandatory)
8.2.7.9.2 Manufacturer name (Mandatory)
8.2.7.9.3 Issuer of ID (Mandatory)
8.2.7.9.4 Manufacturer role (Mandatory)
8.3 Specified Substance Group 2 Extended (Conditional)
8.3.1 Specified Substance Group 2 ID (Mandatory)
8.3.2 Substance Name (Mandatory)
8.3.3 Substance code (Conditional)
8.3.4 Reference source (Conditional)
8.3.4.1 Reference source document (Conditional)
8.3.5 Reference information (Conditional)
8.3.6 Version (Mandatory)
8.3.7 Manufacturing (Mandatory)
8.3.7.1 Manufacturing type (Conditional)
8.3.7.2 Production method type (Conditional)
8.3.7.3 Production method description (Conditional)
8.3.7.4 Production system type (Conditional)
8.3.7.5 Production system (Conditional)
8.3.7.6 Critical process version number (Conditional)
8.3.7.7 Version (Mandatory)
8.3.7.8 Version date (Mandatory)
8.3.7.9 Organization (Mandatory)
8.3.7.10 Production step (Conditional)
8.3.7.10.1 Process site ID (Conditional)
8.3.7.10.2 Process site name (Conditional)
8.3.7.10.3 Step number (Conditional)
8.3.7.10.4 Geographical coordinates (Mandatory)
8.3.7.10.5 Starting material (Conditional)
8.3.7.10.5.1 Starting material type (Conditional)
8.3.7.10.5.2 Manufacturing material substance (Mandatory)
8.3.7.10.5.2.1 Manufacturing material substance ID (Mandatory)
8.3.7.10.5.2.2 Manufacturing material substance name (Mandatory)
8.3.7.10.5.2.3 Grade type (Conditional)
8.3.7.10.5.2.4 Amount (Conditional)
8.3.7.10.5.2.5 Reference range (Conditional)
8.3.7.10.6 Processing material (Conditional)
8.3.7.10.6.1 Processing material type (Conditional)
8.3.7.10.7 Resultant material (Mandatory)
8.3.7.10.7.1 Resultant material type (Mandatory)
8.3.7.10.7.2 Holding time (Conditional)
8.3.7.10.7.3 Storage conditions (Conditional)
8.3.7.10.7.3.1 7.3.7.10.7.3.1 Manufacturing material substance (Mandatory)
8.4 Specified Substance Group 3 (Conditional)
8.4.1 Specified Substance Group 3 ID (Mandatory)
8.4.2 Substance Name (Mandatory)
8.4.3 Grade (Mandatory)
8.4.3.1 Grade type (Mandatory)
8.4.3.2 Grade name (Mandatory)
8.4.4 Version (Mandatory)
8.4.5 Substance code (Conditional)
8.4.6 Reference information (Conditional)
8.4.7 Reference source (Conditional)
8.4.7.1 Reference source document (Conditional)
9 Description of the information modelling principles and practices
9.1 General considerations
9.2 Conceptual overview diagrams
9.3 Section high-level diagrams
9.4 Detailed diagrams
9.4.1 Relationships between classes
9.4.2 Notes
9.4.3 Attributes
9.4.4 Message exchange format
9.4.5 Conformance terminology and context as it relates to the ISO 11238 and ISO/TS 19844 exchange format
Annex A (normative)Choosing a Substance ID
A.1 General
A.2 Requesting a Substance ID and providing information
Annex B (informative)Chemical substance
B.1 Introduction
B.1.1 Molecular Weight, Moiety and Amount for stoichiometric chemical substances
B.1.2 Relations with other Element Groups (see Figure B.2)
B.1.2.1 Element Group: Moiety
B.1.2.2 Element Group: Substance Relationship
B.1.2.3 Requesting a Substance ID
B.2 Outline of Annex B
B.3 Scope
B.4 Terms and definitions
B.5 Chemical Substance subtypes and Mixture
B.5.1 Substance type, Chemical substance
B.5.1.1 Stoichiometric chemical substances
B.5.2 Solid state forms of the Substance
B.5.2.1 Co-crystals
B.5.2.2 Solvates and hydrates
B.5.3 Need to substantiate the chemical structure, molecular formula and molecular weight
B.5.4 Polymorphism
B.5.4.1 Example: Tibolone [C21H28O2]
B.5.5 Non-stoichiometric chemical substances
B.5.5.1 Example: USP monograph: Aluminium Chlorohydrex Propylene Glycol
B.5.5.2 Example: Octeotride Acetate
B.5.6 Mixture
B.5.6.1 Teicoplanin (Ph.Eur.)
B.5.7 Multi-substance material
B.5.7.1 Example: Paclitaxel-Albumin complex
B.6 Discussion of the key elements of a chemical substance
B.6.1 Identity of material
B.6.2 Nomenclature
B.6.3 Molecular formula
B.6.4 Molecular weight
B.6.5 Substance structure
B.6.5.1 Stereochemistry
B.6.5.2 General aspects of stereochemistry
B.6.6 Geometric isomerism
B.6.6.1 (E/Z) isomerism
B.6.6.2 Cis-Trans Ring-isomerism
B.6.7 Substance with two centres of Asymmetry, Epimers, Diastereomers
B.6.8 Anomers
B.6.9 Substance with more than two centres of Asymmetry (Mixture of stereoisomers)
B.6.10 Conclusion for the Key elements
B.6.11 Decision tree for a new Substance ID
B.7 Discussing other elements of importance regarding the characteristics of a substance
B.7.1 Introduction
B.7.2 Naming Vegetable Oils
B.7.3 Example Olive Oil, Virgin
B.7.4 Description of Elements at the Specified Substance Group 1 Information level
B.7.5 Description of Elements at the Specified Substance Group 2 Information level
B.7.6 Description of Elements at the Specified Substance Group 3 Information level
B.7.7 Olive Oil, Refined
B.7.8 Properties to be captured, related to liquids (vegetable oils)
B.7.8.1 Example: Identity of material, combining the elements for Olive Oil, Virgin (Ph.Eur.) and Olive Oil, Refined (Ph.Eur.)
B.7.9 Castor Oil and related products
B.7.9.1 Castor Oil, Virgin (Ph.Eur.)
B.7.9.2 Castor Oil, Hydrogenated (Ph.Eur.)
B.7.9.3 Explanation of the differences between Castor Oil, Virgin and Castor Oil, Hydrogenated
B.7.9.4 Castor Oil, Ethoxylated
B.7.10 Properties related to liquids (Gas), Nitrous oxide
B.8 Examples
B.8.1 Example 1: Amlodipine besilate
B.8.2 Example 2: Ponatinib hydrochloride
B.8.3 Example 3: Benzathine Benzylpenicillin tetrahydrate, sterilized.
B.9 Radiopharmaceutical substance
B.9.1 Introduction
B.9.2 Example: Florbetapir 18F
Annex C (normative)Protein substance
C.1 Introduction
C.2 Scope
C.3 Terms and definitions
C.4 Peptide Substances
C.4.1 Example: Vasopressin
C.4.2 Example IIIb: Desmopressin
C.4.3 Example: Desmopressin Acetate
C.4.4 Calcitonin Salmon
C.4.5 Example: Human Insulin
C.5 Element Group Protein, Specified Substance Group 1
C.5.1 Example: Insulin Human Zinc Suspension (Amorphous), taken from Ph.Eur./USP Monographs for Zinc Suspensions
C.5.2 Example: Insulin Human Zinc Suspension (Crystalline), taken from Ph.Eur./USP Monographs for Zinc Suspensions
C.5.3 Example: Insulin Human Zinc Suspension taken from Ph.Eur./USP Monographs for Zinc Suspensions, including discussion for Specified Substance Group 3 information
C.6 Element Group Protein, Specified Substance Group 2
C.6.1 Example: Synthetic Calcitonin Salmon-Manufacturer Company Acme
C.6.2 Example: Recombinant Calcitonin Salmon — Company Acme
C.7 Element Group Protein, Specified Substance Group 3
C.7.1 Example: Calcitonin Salmon (Synthetic) Specified Substance Group 3
C.7.2 Example: Calcitonin Salmon (Recombinant) Specified Substance Group 3
C.8 Example Protein Substance: Monoclonal Antibody Conjugated Toxin
C.9 Addendum: Microheterogeneity
C.9.1 Microheterogeneity
C.9.2 Introduction
C.9.3 Brentuximab Glycans
C.9.4 Structuring Monoclonal Glycans at the Specified Substance Information level
C.9.5 Example: Brentuximab Vedotin –Company XYZ.
C.9.6 Brentuximab Vedotin–In-house Grade.
Annex D (informative)Nucleic acid substance
D.1 Introduction
D.2 Scope
D.3 Terms and definitions
D.4 Examples
D.4.1 Example: 5-Methylcytosine
D.4.2 Example: A 5’-phosphate ribonucleotide
D.4.3 Residues involved in the internucleotide linkage.
D.5 Substances
D.5.1 Example: Mipomersen sodium information
D.5.2 Oligonucleotide Elements
D.5.2.1 Example Nucleic Acid Substance: Mipomersen sodium
D.5.2.2 Example: Nucleic Acid Substance: Litenimod
D.5.2.3 Example: Anti-sense RNA
Annex E (normative)Structurally Diverse Substance — Herbal Substance/Herbal Specified Substance
E.1 Scope
E.2 Introduction
E.2.1 Structurally Diverse Substance type
E.2.2 Organism Taxonomy
E.2.3 Substance Names
E.2.3.1 Substance (fresh) Name
E.2.3.2 Substance (Herbal Drug)
E.2.3.3 Substance (Herbal preparation)
E.2.4 Examples of Substance (fresh) and Substance (Herbal Drug) Names
E.2.5 Specified Substance Group 1, 2 and 3 information
E.2.5.1 Specified Substance Group 1 Name:
E.2.5.2 Specified Substance Group 2 Name:
E.2.5.3 Specified Substance Group 3 Name
E.2.5.4 Overview of the Naming connections of the Botanical Material for the Substance and Specified Substance Group 1, 2, 3 Levels
E.2.6 Specified Substance Group 1 Information
E.2.7 Specified Substance Group 2 Information
E.2.8 Substance and Specified Substance information for Iberis amara L, Whole Plant and of the liquid extract. (Simplified example)
E.2.9 Specified Substance Group 2 Information for Iberis amara, Whole Plant, liquid extract (Extended Information)
E.2.10 Specified Substance Group 3 Information
E.3 Terms and definitions
E.3.1 Definitions according to Directive 2001/83/EC and Directive 2004/24/EC, Title 1, Definitions
E.3.2 Definitions according to the European Pharmacopoeia
E.4 Documentation and Explanation of Example 1
E.4.1 Example Ginkgo biloba, leaf taken from the European Pharmacopoeia
E.4.2 Herbal preparation Ginkgo biloba extract, Limited information: Description of the elements at the Substance information level
E.4.2.1 Herbal preparation Ginkgo biloba extract, Limited information: Description of the elements at the Specified Substance Group 1, 2 and 3.
E.4.2.2 Herbal preparation Ginkgo biloba extract, Extended information: Description of the elements at the Specified Substance Group 1, 2 and 3.
E.4.3 Example 2: Devil’s Claw Root (Ph.Eur.), continued
E.4.3.1 General Information Herbal Drug
E.4.3.2 General Information Herbal preparation
E.4.4 Organization of the information according to ISO 11238 and ISO/TS 19844
E.4.4.1 Information at the Substance level
E.4.4.2 Substance (Fresh)
E.4.4.3 Substance (Usually Dry, may be Fresh as described in a Pharmacopoeia) = Herbal Drug
E.4.4.4 Substance, Herbal preparation
E.4.4.5 Specified Substance Group 1 information level for the Herbal Drug
E.4.4.6 Specified Substance Group 2 information level for the Herbal Drug
E.4.4.7 Specified Substance Group 3 information level for the Herbal Drug
E.4.4.8 Elements captured at the Specified Substance Group 1 level for the Herbal preparation (Extract, extended information)
E.4.4.9 Elements captured at the Specified Substance Group 2 level for the Herbal preparation (Extract, extended information)
E.4.4.10 Elements captured at the Specified Substance Group 3 level for the Herbal preparation (Extract, extended information)
E.4.5 Summary of the Organization of the information for Devil’s Claw
E.5 Documentation and Explanation of Example 3
E.5.1 Example 3: Salvia Miltiorrhiza Root and Rhizome (BP=Ph.Eur.) and Chinese Salvia (USP), continued.
E.5.1.1 Specifications according to the USP and Ph.Eur.:
E.5.1.2 Submitted Data
E.5.2 Herbal preparation: Salvia Miltiorrhiza Extract provided information
E.5.3 Organization of the information according to ISO 11238 and ISO/TS 19844
E.5.3.1 Substance information level
E.5.3.1.1 Substance (fresh)
E.5.3.1.2 Substance (Herbal Drug)
E.5.3.1.3 Substance (Herbal preparation)
E.5.3.2 Specified Substance Group 1 information level (Herbal Drug)
E.5.3.3 Specified Substance Group 2 information level (Herbal Drug)
E.5.3.4 Specified Substance Group 3 information level (Herbal Drug)
E.5.4 Specified Substance Group 1 information level of Herbal preparation (Extract, extended information)
E.5.4.1 Specified Substance Group 2 information level of the Herbal preparation (Extract, extended information)
E.5.4.2 Specified Substance Group 3 information level (Herbal preparation)
E.6 Documentation and Explanation of Example 4
E.6.1 Herbal preparations Olive Oil, Virgin (Ph.Eur.) and Olive Oil, Refined (Ph.Eur.)
E.6.1.1 Olive Oil, Virgin (Ph.Eur.)
E.6.1.2 Elements to be described at the Substance (fresh) and Substance (Herbal preparation) level
E.6.1.3 Elements to be described at the Specified Substance Group 3 Information level (Herbal preparation).
E.7 Documentation and Explanation of Example 5
E.7.1 JP XVI monograph Shakuyakukanzoto Extract, see Figure E.38.
E.7.2 JP Monograph for Preparations Related to Crude Drugs, I. Extract
E.7.3 JP Monograph of the Crude Drugs (starting materials) JP monograph Peony Root and Glycyrrhiza
E.7.4 Organization of the information in accordance to ISO 11238 and ISO/TS 19844
E.7.4.1 Information captured at the Substance level for Glycyrrhiza (JP)
E.7.4.2 Substance (Fresh)
E.7.4.2.1 Substance (Fresh)
E.7.4.3 Substance (Herbal Drug)
E.7.4.4 Information captured at the Group 1 Specified Substance level for the Herbal Drug Glycyrrhiza (JP)
E.7.4.5 Information captured at the Substance level for Peony Root (JP)
E.7.4.6 Information captured at the Substance level for Peony Root (JP)
E.7.4.7 Information captured at the Group 1 Specified Substance level for the Herbal Drug Peony Root (JP)
E.7.4.8 Information captured at the Substance level for the Herbal preparation Shakuyakukanzoto Extract
E.7.4.9 Information captured at the Group 1 Specified Substance level for Shakuyakukanzoto Extract (JP)
E.7.4.10 Information captured at the Specified Substance Group 2 level for Shakuyakukanzoto Extract (JP)
E.7.4.11 Information captured at the Group 3 Specified Substance level for Shakuyakukanzoto Extract (JP)
E.8 General Information on the use of Glycyrrhiza species and their constituents
E.8.1 Herbal preparation, Liquorice extract
E.9 Exudates
E.9.1 Examples
E.9.1.1 Peru balsam, Ph.Eur. monograph 01/2008:0754
E.9.1.2 Production of Peru Balsam
E.9.1.3 Tolu balsam, Ph.Eur. monograph 01/2008:1596
E.9.1.4 Production of Tolu Balsam
E.9.2 Conclusion
E.10 Peru Balsam/Tolu Balsam structuring information
E.10.1 Capturing information for Peru Balsam (Ph.Eur.) at the Substance information level
E.10.1.1 Substance (Fresh)
E.10.1.2 Substance (Herbal preparation)
E.10.2 Capturing information for Peru Balsam (Ph.Eur.) at the Specified Substance information level
E.10.2.1 Element Group: Specified Substance Group 1
E.10.2.2 Element Group: Specified Substance Group 2
E.10.2.3 Element Group: Specified Substance Group 3
E.10.3 Capturing information for Tolu Balsam (Ph.Eur.)
E.10.3.1 Substance (Fresh)
E.10.3.2 Substance (Herbal preparation)
E.10.4 Specified Substance information level
E.10.4.1 Element Group: Specified Substance Group 1
E.10.4.2 Element Group: Specified Substance Group 2
E.11 Comparison table
Annex F (informative)Structurally Diverse Substance, Homeopathic substance
F.1 Introduction
F.1.1 Introduction
F.1.2 Homeopathy and the use of homeopathic medicinal products
F.1.3 Legislation and regulatory requirements
F.2 Manufacturing of homeopathic medicinal products/homeopathic references
F.2.1 Legislation and regulatory requirements
F.3 Specific Definitions of Homeopathic Manufacturing
F.3.1 Homeopathic Stocks
F.3.2 Homeopathic preparation
F.3.3 Homeopathic Dilutions
F.3.3.1 Decimal dilution/decimal potencies
F.3.3.2 Centesimal dilution/centesimal potencies
F.3.3.3 LM – potencies
F.3.3.4 Korsakovian potencies
F.3.3.5 Methods of preparation of homeopathic stocks and potentization
F.3.3.6 Mother Tincture
F.3.3.7 Nosode
F.3.3.8 Potentization
F.3.3.9 Raw material
F.3.3.10 Succussion
F.3.3.11 Vehicle
F.3.4 Dosage Forms
F.3.5 Homeopathic Stocks and Raw Materials
F.3.6 Classification of Homeopathic Stocks and Homeopathic Dilutions (in accordance with ISO 11238 and ISO/TS 19844)
F.3.6.1 Homeopathic starting material
F.3.6.2 Capturing Information at the Specified Substance Group 1 information level
F.3.6.3 Substance Dilution Potentization
F.3.6.3.1 Decimal dilution/decimal potencies
F.3.6.3.2 Centesimal dilution/centesimal potencies
F.3.6.3.3 LM – potencies
F.3.6.4 Vehicle
F.3.6.5 Organism Taxonomy of Structural Diverse Substance Type, e.g. Herbal and Zoological Organism
F.3.7 Capturing of the Homeopathic medicine (Stock. Dilution Grade, Dilution method)
F.3.7.1 Substance information level: (Homeopathic Substance)
F.3.7.2 Specified Substance Group 1: (Herbal)
F.3.7.3 Specified Substance Group 2
F.3.7.4 Specified Substance Group 3:
F.3.8 Nomenclature of Homeopathic Medicines
F.3.9 Nomenclature of Homeopathic Medicines
F.3.10 Nomenclature according to homeopathic tradition
F.3.11 Nomenclature according to homeopathic tradition
F.4 Examples in tabular format
F.4.1 Structured information of material combining the elements for Arnica montana 6DH, Substance of botanical origin according to the French tradition
F.4.2 Structured information of material, combining the elements for Arnica montana D6, Substance of botanical origin according to the German tradition
F.4.3 Structured information of material, combining the elements for Arsenicum album C30 Substance of chemical origin according to the German tradition
F.4.4 Structured information of material, combining the elements for Lachesis 200K, Substance of zoological origin according to the Korsakovian dilution method
F.4.5 Structured Information of material, combining the elements for Pyrit D2, Substance of mineral origin according to the German tradition.
Annex G (informative)Structurally Diverse Substance — Plasma-derived substances
G.1 Scope
G.2 General Aspects of Plasma-derived Substances
G.2.1 Source material
G.2.2 Manufacturing process
G.2.3 Adventitious agents
G.2.4 Substance classification for plasma-derived products
G.2.4.1 General Remarks
G.2.4.2 Manufacturing plasma pool/Plasma for fractionation (Ph.Eur. monograph 0853)
G.2.4.3 Cryoprecipitate and Cryopoor plasma
G.2.4.4 Plasma-derived substance
G.3 Terms and definitions
G.4 Structuring the required information
G.4.1 Substance information level
G.4.2 Country of plasma origin
G.4.3 Reference Source and Reference Source Document
G.4.4 Testing strategy
G.4.5 Summary of the information regarding Cryoprecipitate and Cryopoor plasma
G.4.6 Substance information example for a plasma-derived Substance/product ‘Human Albumin, Plasma-derived', Part 1: Cryopoor plasma
G.4.7 Specified Substance Group 1 Information level
G.4.8 Summary
G.4.9 Specified Substance Group 2 Information level
G.4.10 Structuring of the plasma-derived substance information
G.4.10.1 Substance Information level
G.4.10.2 Specified Substance Group 2 Information level
G.4.10.3 Specified Substance Group 3 Information level: specifications
G.4.11 Virus Risk Assessment
G.5 Example Plasma-derived Factor VIII + VWF
G.5.1 Introduction/background information for FVIII example
G.5.2 General discussion of the structure of FVIII
G.5.2.1 Molecular characterization of FVIII
G.5.2.2 Tabular information of the FVIII example at the Substance information level
G.5.2.3 Information of the FVIII example at the Specified Substance Group 2 information level
Annex H (normative)Polymer substance
H.1 Introduction
H.2 Scope
H.3 Terms and definitions
H.4 Data elements
H.4.1 Polymer Class
H.4.2 Polymer Geometry
H.4.3 Copolymer connectivity
H.4.4 Structural Repeat Unit (SRU)
H.4.5 Degree of Polymerization
H.4.6 Monomers, Polymer starting material
H.4.7 Molecular Weight
H.4.8 Property
H.4.9 Modification
H.4.10 Source Material
H.5 Linear Synthetic Polymers
H.5.1 Example1: Polyethylene Glycol 3350
H.6 Modified Linear Polymers
H.6.1 Example 2: Hypromellose 2910 (4000 mPa.s)
H.7 Linear Block Copolymers
H.7.1 Example 3: Poloxamer 338
H.7.2 Poloxamer 338 Specified Substance Group 2 information Level
H.7.3 Poloxamer Specified Substance Group 3
H.8 Linear Biologically Sourced Polymers
H.8.1 Glycosaminoglycans
H.8.2 Heparins
H.8.3 Example 4: Heparin Sodium
H.9 Nucleic Acids
H.9.1 Defibrotide (Porcine)
Annex I (informative)Structurally diverse vaccines
I.1 Scope
I.2 Introduction
I.2.1 Introduction
I.2.2 Types of Vaccines Antigens
I.2.3 Strategy for Defining Vaccines
I.2.4 Recombinant Proteins
I.3 Terms and definitions
I.4 Example: Hepatitis B vaccines
I.4.1 Background information of Hepatitis B S protein
I.4.2 Development of hepatitis B vaccine from transformed yeast cells
I.4.3 Capturing information for Hepatitis B Surface Antigen Virus-like particles produced in yeast cells
I.4.4 Capturing manufacturing information for Hepatitis B Surface Antigen Virus-like particles produced in yeast cells
I.4.5 Capturing manufacturing information for Hepatitis B Surface Antigen Virus-like particles produced in yeast cells
I.5 Example: Live attenuated Vaccines, BCG vaccine, Freeze-dried and BCG for immunotherapy
I.5.1 General information about the BCG strain
I.5.2 Capturing information for a live attenuated vaccine following the Structurally diverse content data model
I.5.3 Substance Name of the Source Material
I.5.4 Strain history and population doublings, general information
I.5.5 Specified Substance Group 1 Information
I.5.6 Information of the BCG-strain: Danish 1331 strain MS and Working seed.
I.6 Bacterial vaccine, inactivated antigen and conjugated to a carrier protein
I.6.1 Definition as described in the Ph. Eur Meningococcal group ACWY Vaccine monograph 01/2008:0250
I.6.2 Description of the substances comprised in Men(ACWY)
I.6.2.1 MenA Polysaccharide and Oligosaccharide Description
I.6.2.2 MenC Polysaccharide and Oligosaccharide Description
I.6.2.3 MenW Polysaccharide and Oligosaccharide Description
I.6.2.4 MenY Polysaccharide and Oligosaccharide Description
I.6.2.5 Requirements as described in the Ph. Eur Meningococcal group ACWY Vaccine monograph 01/2008:0250
I.6.2.5.1 Production
I.6.2.5.2 Seed Lots
I.6.2.5.3 Propagation and Harvest
I.6.3 History of the strain
I.6.3.1 Taxonomic information
I.6.3.2 Master Seed
I.6.3.3 Working Seed
I.6.3.4 Propagation and Harvesting
I.6.3.5 Downstream Purification of the Crude Polysaccharides
I.6.4 Coupling to a Carrier Protein
I.6.5 CRM197 Coupling mechanism to polysaccharides
I.6.6 Requirements of the Degree of Polymerization [78]
I.6.7 New strategies concerning type coupling and type of glycan structure conjugates
I.6.8 Registration of CRM197
I.6.9 Capturing the information of Meningococcal conjugated vaccine according to ISO/TS 19844
I.7 Tabular information for CRM197
I.7.1 Specified Substance Group 1 Information for Corynebacterium diphtheriae CRM197 protein
I.7.2 Specified Substance Group 2 Information for Corynebacterium diphtheriae CRM197 protein
I.7.3 Specified Substance Group 3 Information for Corynebacterium diphtheriae CRM197 protein
I.8 Tabular information for Meningococcal ACWY conjugate vaccine
I.8.1 Registration of Tabular Information N. meningitidis group A oligosaccharide conjugated to CRM197 protein
I.8.2 Specified Substance Group 1 Information for N. Meningitidis group A polysaccharide
I.8.3 Specified Substance Group 2 Information for N. Meningitidis group A polysaccharide
I.8.4 Specified Substance Group 3 Information for N. Meningitidis group A polysaccharide
I.8.5 Substance Information for N. Meningitidis group A oligosaccharide conjugated to CRM197 protein
I.9 Registration of Tabular Information N. meningitidis group C oligosaccharide conjugated to CRM197 protein
I.9.1 Registration of N. meningitidis group C polysaccharide
I.9.2 Specified Substance Group 1 Information for N. Meningitidis group C polysaccharide
I.9.3 Specified Substance Group 2 Information for N. Meningitidis group C polysaccharide
I.9.4 Specified Substance Group 3 Information for N. Meningitidis group C polysaccharide
I.9.5 Substance Information for N. Meningitidis group C oligosaccharide conjugated to CRM197
I.10 Registration of Tabular Information N. meningitidis group W oligosaccharide conjugated to CRM197 protein
I.10.1 Registration of N. meningitidis group W polysaccharide
I.10.2 Specified Substance Group 1 Information for N. Meningitidis group W polysaccharide
I.10.3 Specified Substance Group 2 Information for N. Meningitidis group W135 polysaccharide
I.10.4 Specified Substance Group 3 Information for N. Meningitidis group C W135 polysaccharide
I.10.5 Substance Information for N. Meningitidis group W135 oligosaccharide conjugated to CRM197 protein
I.11 Registration of Tabular Information N. meningitidis group Y oligosaccharide conjugated to CRM197 protein
I.11.1 Registration of N. meningitidis group Y polysaccharide
I.11.2 Specified Substance Group 1 Information for information Neisseria Meningitidis group Y polysaccharide
I.11.3 Specified Substance Group 2 Information for Neisseria Meningitidis group Y polysaccharide
I.11.4 Specified Substance Group 3 Information for Neisseria Meningitidis group Y polysaccharide
I.11.5 Substance Information for Neisseria Meningitidis group Y oligosaccharide conjugated to CRM197
I.12 Influenza vaccines
I.12.1 Influenza vaccines, International requirements
I.12.2 Influenza vaccines, Haemagglutinin and Neuramidase antigens
I.12.3 Influenza vaccines Nomenclature
I.12.4 Manufacture of a split vaccine
I.12.5 Information to be captured in accordance to ISO 11238 and ISO/TS 19844
I.12.6 Substance Name
I.12.7 Specified Substance Group 1 Information for Influenza A virus A/California/7/2009 (H1N1) pdm09-like virus used A/Christchurch/16/2010 (H1N1), NIB-74xp
I.12.8 Specified Substance Group 2 Information for Influenza A virus A/California/7/2009 (H1N1) pdm09-like virus used A/Christchurch/16/2010 (H1N1), NIB-74xp
Annex J (informative)Structurally diverse allergen substances
J.1 Introduction
J.2 Scope
J.3 Terms and definitions
J.4 General aspects of allergen substances
J.4.1 Allergens and allergies
J.4.2 Source material
J.5 Characterization of the allergen preparation
J.5.1 In-house reference preparation
J.5.2 Identification
J.5.3 Tests and properties
J.6 Characterization of the Major allergens in an allergen preparation
J.6.1 Example 1: Identification of Major allergens in House dust mite (HDM).
J.6.1.1 Introduction
J.6.1.2 Group 1 Allergens, structure information
J.6.1.3 Group 2 Allergens, structure information
J.6.2 Description of the Allergenic Substance in a standardized allergen extract of HDM
J.6.2.1 Composition of Allergenic Substances in the HDM SLIT-tablet
J.6.2.2 Isolation of the Group 1 and Group 2 allergens from the source material
J.6.2.3 Structuring the Source Material information according to ISO 11238 and ISO/TS 19844.
J.6.2.4 Summary of organization the Substance and Specified Substance information for the Dermatophagoides species, without modification.
J.7 Example Grass pollens (modified)
J.7.1 Introduction to the grass pollen extract
J.7.2 Organization of the grass pollen extract in accordance to the ISO content data models
Annex K (informative)Advanced therapies and advanced vaccines(genes, modified viruses, cells and tissues as substances) (placeholder)
K.1 Scope
K.2 Introduction
K.3 Substances in Advanced Therapies
K.3.1 Genes
K.3.2 Silencing genes
K.3.2.1 Anti-sense oligonucleotides
K.3.2.2 Si-RNA
K.3.3 Gene therapy products
K.3.3.1 Naked, complexed or liposomal DNA
K.3.3.2 Transducing viral vectors
K.3.3.3 Gene modified Cells
K.3.3.4 Genetically modified bacteria
K.3.3.5 Zincfinger CRISPR-cas
K.3.4 Cell therapy products
K.3.4.1 Stem and progenitor cells
K.3.4.2 Differentiated cells
K.3.4.3 Antigen primed cells
K.3.5 Tissue engineered products and engineered tissues
K.3.5.1 Tissue engineered products
K.3.5.2 Scaffolds and decellularized matrices
K.3.5.3 Engineered tissues
K.4 Substances in Advanced Vaccines against infectious diseases
K.4.1 Nucleic acid vaccines
K.4.2 Recombinant viruses
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General background and history
6 Substance (Mandatory)
6.1 General
6.2 Defining substances
6.2.1 Substance type (Mandatory)
6.2.2 Substance ID (Mandatory)
6.3 Substance names (Mandatory)
6.3.1 Substance name (Mandatory)
When requesting an ID, a submitter should submit all names and company codes which have been associated with the substance. A submitter may also want to add a name to a substance that is already in the database. Defining information for a given substance should also be transmitted when requesting that a name is added to the database to ensure the correct substance identity. A submitter may also submit names in multiple languages. Although there is no requirement that names are unique, other or common names should also explicitly distinguish related substances from one another. Distinguishing characteristics for many polymers, such as molecular weight, degree of polymerization, and viscosity, should be indicated in the names of these substances. Standardization on such names to facilitate searching and identification of substances may be adopted within regions.
6.3.2 Substance name type (Mandatory)
6.3.3 Language (Mandatory)
6.3.4 Substance name domain (Conditional)
6.3.5 Jurisdiction (Conditional)
6.3.6 Official name (Conditional)
6.3.6.1 Official name type (Mandatory)
6.3.6.2 Official name status (Conditional)
6.3.6.3 Official name status change date (Conditional)
6.4 Reference source (Conditional)
6.4.1 Public domain (Conditional)
6.4.2 Reference source type (Mandatory)
6.4.3 Reference source class (Optional)
6.4.4 Reference source ID (Conditional)
6.4.5 Reference source citation (Conditional)
6.4.6 Reference source URL (Conditional)
6.4.7 Reference source document (Conditional)
6.4.7.1 Public domain (Conditional)
6.4.7.2 Reference source document (Optional)
6.4.7.3 Reference source document type (Optional)
6.4.7.4 Reference source document ID (Optional)
6.4.7.5 Reference source document classification (Optional)
6.5 Substance code (Conditional)
6.5.1 Code (Mandatory)
6.5.2 Code system (Mandatory)
6.5.3 Code system ID (Mandatory)
6.5.4 Code system status (Mandatory)
6.5.5 Code change date (Optional)
6.5.6 Comment (Optional)
6.5.7 Reference source (Conditional)
6.5.7.1 Reference source document (Conditional)
6.6 Reference information (Conditional)
6.6.1 Comment (Optional)
6.6.2 Substance classification (Conditional)
6.6.2.1 Domain (Optional)
6.6.2.2 Substance classification (Optional)
6.6.2.3 Substance classification code (Optional)
6.6.2.4 Substance classification type (Optional)
6.6.2.5 Substance classification subtype (Optional)
6.6.2.5.1 Substance class subtype (Optional)
6.6.2.6 Reference source (Conditional)
6.6.3 Substance relationship (Conditional)
6.6.3.1 Related substance ID (Conditional)
6.6.3.2 Related substance name (Conditional)
6.6.3.3 Relationship (Conditional)
6.6.3.4 Relationship type (Optional)
6.6.3.5 Is Defining (Mandatory)
6.6.3.6 Amount (Conditional)
6.6.3.6.1 Reference range (Conditional)
6.6.3.7 Reference source (Optional)
6.6.3.7.1 Reference source document (Optional)
6.6.4 Target (Conditional)
6.6.4.1 Target ID (Conditional)
6.6.4.2 Target name (Conditional)
6.6.4.3 Interaction type (Conditional)
6.6.4.4 Target organism (Conditional)
6.6.4.5 Target organism type (Conditional)
6.6.4.6 Target type (Optional)
6.6.4.7 Amount (Conditional)
6.6.4.7.1 Reference range (Conditional)
6.6.4.8 Reference source (Optional)
6.6.4.8.1 Reference source document (Optional)
6.6.5 Gene (Conditional)
6.6.5.1 Gene sequence origin (Conditional)
6.6.5.2 Gene ID (Conditional)
6.6.5.3 Gene name (Conditional)
6.6.5.4 Reference source (Conditional)
6.6.5.4.1 Reference source document (Optional)
6.6.6 Gene element (Conditional)
6.6.6.1 Gene element type (Conditional)
6.6.6.2 Gene element ID (Conditional)
6.6.6.3 Gene element name (Conditional)
6.6.6.4 Reference source (Conditional)
6.6.6.4.1 Reference source document (Optional)
6.7 Structure (Conditional)
6.7.1 Stereochemistry (Conditional)
6.7.2 Optical activity (Conditional)
6.7.3 Molecular Formula (Conditional)
6.7.4 Molecular Formula by Moiety (Conditional)
6.7.5 Molecular weight (Mandatory)
6.7.6 Structural Representation (Conditional)
6.7.6.1 Structural representation type (Conditional)
6.7.6.2 Structural representation (Conditional)
6.7.6.3 Structural representation attachment (Optional)
6.7.7 Isotope (Conditional)
6.7.7.1 Nuclide ID (Conditional)
6.7.7.2 Nuclide name (Conditional)
6.7.7.3 Substitution type (Conditional)
6.7.7.4 Nuclide Half Life (Optional)
6.7.7.5 Amount (Conditional)
6.7.7.5.1 Reference range (Conditional)
6.7.7.6 Molecular weight (Mandatory)
6.7.8 Reference Source (Conditional)
6.7.8.1 Reference source document (Conditional)
6.8 Amount (Conditional)
6.8.1 Amount type (Conditional)
6.8.2 Quantity (Conditional)
6.8.3 Low limit (Conditional)
6.8.4 High limit (Conditional)
6.8.5 Unit (Conditional)
6.8.6 Non-numeric Value (Conditional)
6.8.7 Amount text (Conditional)
6.8.8 Reference range (Conditional)
6.8.8.1 Low limit (Conditional)
6.8.8.2 High limit (Conditional)
6.8.8.3 Unit (Conditional)
6.9 Source material (Conditional)
6.9.1 Source material class (Conditional)
6.9.2 Source material type (Conditional)
6.9.3 Source material state (Conditional)
6.9.4 Organism ID (Conditional)
6.9.5 Organism name (Conditional)
6.9.6 Parent substance ID (Conditional)
6.9.7 Parent substance name (Conditional)
6.9.8 Country of origin (Conditional)
6.9.9 Geographical location (Conditional)
6.9.10 Development stage (Conditional)
6.9.11 Part Description (Conditional)
6.9.11.1 Part (Mandatory)
6.9.11.2 Part location (Conditional)
6.9.11.3 Reference source (Conditional)
6.9.11.3.1 Reference source document (Conditional)
6.9.12 Fraction description (Conditional)
6.9.12.1 Fraction (Conditional)
6.9.12.2 Material type (Conditional)
6.9.12.3 Reference Source (Conditional)
6.9.12.3.1 Reference source document (Conditional)
6.9.13 Organism (Conditional)
6.9.13.1 Family (Conditional)
6.9.13.2 Genus (Conditional)
6.9.13.3 Species (Conditional)
6.9.13.4 Intraspecific type (Optional)
6.9.13.5 Intraspecific description (Conditional)
6.9.13.6 Author (Conditional)
6.9.13.6.1 Author type (Conditional)
6.9.13.6.2 Author description (Conditional)
6.9.13.7 Organism general (Conditional)
6.9.13.7.1 Kingdom (Conditional)
6.9.13.7.2 Phylum (Conditional)
6.9.13.7.3 Class (Conditional)
6.9.13.7.4 Order (Conditional)
6.9.13.8 Hybrid (Conditional)
6.9.13.8.1 Hybrid species maternal organism ID (Optional)
6.9.13.8.2 Hybrid species maternal organism name (Optional)
6.9.13.8.3 Hybrid species paternal organism ID (Optional)
6.9.13.8.4 Hybrid species paternal organism name (Optional)
6.9.13.8.5 Hybrid type (Conditional)
6.10 Modification (Conditional)
6.10.1 Modification type (Conditional)
6.10.2 Residue modified (Conditional)
6.10.3 Residue site (Conditional)
6.10.4 Structural modification (Conditional)
6.10.4.1 Structural modification type (Conditional)
6.10.4.2 Moiety (Conditional)
6.10.4.2.1 Amount (Conditional)
6.10.4.2.1.1 Reference range (Conditional)
6.10.4.3 Molecular fragment (Conditional)
6.10.4.3.1 Molecular fragment role (Conditional)
6.10.4.3.2 Molecular fragment ID (Mandatory)
6.10.4.3.3 Molecular fragment name (Mandatory)
6.10.4.3.4 Amount (Conditional)
6.10.4.3.5 Structure (Conditional)
6.10.5 Agent modification (Conditional)
6.10.5.1 Agent modification type (Mandatory)
6.10.5.2 Role (Mandatory)
6.10.5.3 Modification agent ID (Conditional)
6.10.5.4 Modification agent (Conditional)
6.10.5.5 Modification process (Conditional)
6.10.5.6 Amount (Conditional)
6.10.5.6.1 Reference range (Conditional)
6.10.6 Physical Modification (Conditional)
6.10.6.1 Role (Mandatory)
6.10.6.2 Number of parameters (Conditional)
6.10.6.3 Parameters (Conditional)
6.10.6.3.1 Parameter (Mandatory)
6.10.6.3.2 Amount (Mandatory)
6.10.6.3.2.1 Reference range (Conditional)
6.11 Property (Conditional)
6.11.1 Property type (Conditional)
6.11.2 Property name (Conditional)
6.11.3 Property parameters (Conditional)
6.11.4 Property substance ID (Conditional)
6.11.5 Property substance name (Conditional)
6.11.6 Amount (Mandatory)
6.11.6.1 Reference range (Conditional)
6.12 Version (Mandatory)
6.12.1 Version number (Mandatory)
6.12.2 Effective date (Mandatory)
6.12.3 Change made (Conditional)
7 Substance definitions
7.1 Chemical substance
7.1.1 Structure (Mandatory)
7.1.2 Stoichiometric/Non-stoichiometric chemicals
7.1.2.1 Stoichiometric chemicals
7.1.2.2 Non-stoichiometric
7.1.3 Stoichiometric (Mandatory)
7.1.4 Number of moieties (Conditional)
7.1.5 Comment (Optional)
7.1.6 Moiety (Conditional)
7.1.6.1 Moiety role (Conditional)
7.1.6.2 Moiety ID (Mandatory)
7.1.6.3 Moiety name (Mandatory)
7.1.6.4 Stereochemistry (Conditional)
7.1.6.5 Optical activity (Conditional)
7.1.6.6 Molecular formula (Conditional)
7.1.6.7 Molecular formula by moiety (Conditional)
7.1.6.8 Amount (Conditional)
7.1.6.8.1 Reference range (Conditional)
7.1.7 Property (Conditional)
7.1.7.1 Amount (Mandatory)
7.1.7.1.1 Reference range (Conditional)
7.1.8 Substance Name (Mandatory)
7.1.9 Substance Code (Conditional)
7.1.10 Version (Mandatory)
7.1.11 Reference information (Conditional)
7.1.12 Reference source (Conditional)
7.1.12.1 Reference source document (Conditional)
7.2 Proteins/peptides
7.2.1 Microheterogeneity
7.2.2 Sequence type (Mandatory)
7.2.3 Number of subunits (Mandatory)
7.2.4 Disulfide linkage (Conditional)
7.2.5 Comment (Optional)
7.2.6 Protein subunit (Mandatory)
7.2.6.1 Subunit (Mandatory)
7.2.6.2 Sequence (Mandatory)
7.2.6.3 Length (Mandatory)
7.2.6.4 Sequence attachment (Conditional)
7.2.6.5 N_Terminal modification ID (Conditional)
7.2.6.6 N_Terminal modification (Conditional)
7.2.6.7 C_Terminal modification ID (Conditional)
7.2.6.8 C_Terminal modification (Conditional)
7.2.7 Molecular weight (Conditional)
7.2.7.1 Molecular weight method (Mandatory)
7.2.7.2 Molecular weight type (Conditional)
7.2.7.3 Amount (Mandatory)
7.2.7.3.1 Reference range (Conditional)
7.2.8 Glycosylation (Conditional)
7.2.8.1 Glycosylation type (Conditional)
7.2.8.2 N_Glycosylation site (Conditional)
7.2.8.3 O-Glycosylation site (Conditional)
7.2.8.4 C-Glycosylation site (Conditional)
7.2.9 Property (Conditional)
7.2.9.1 Amount (Mandatory)
7.2.9.1.1 Reference range (Conditional)
7.2.10 Structure (Conditional)
7.2.11 Substance name (Mandatory)
7.2.12 Modification (Conditional)
7.2.13 Substance code (Conditional)
7.2.14 Source material (Conditional)
7.2.15 Version (Mandatory)
7.2.16 Reference information (Conditional)
7.2.17 Reference source (Conditional)
7.2.17.1 Reference source document (Conditional)
7.3 Nucleic acids
7.3.1 Structure (Conditional)
7.3.2 Sequence type (Mandatory)
7.3.3 Number of subunits (Mandatory)
7.3.4 Area of hybridization (Conditional)
7.3.5 Oligo nucleotide type (Conditional)
7.3.6 Comment (Optional)
7.3.7 Nucleic acid subunit (Mandatory)
7.3.7.1 Subunit (Mandatory)
7.3.7.2 Sequence (Mandatory)
7.3.7.3 Length (Mandatory)
7.3.7.4 Sequence attachment (Conditional)
7.3.7.5 Five prime ID (Conditional)
7.3.7.6 Five prime (Conditional)
7.3.7.7 Three prime ID (Conditional)
7.3.7.8 Three prime (Conditional)
7.3.7.9 Sugar (Conditional)
7.3.7.9.1 Sugar ID (Mandatory)
7.3.7.9.2 Sugar name (Mandatory)
7.3.7.9.3 Residue site (Mandatory)
7.3.7.10 Linkage (Conditional)
7.3.7.10.1 Linkage connectivity (Conditional)
7.3.7.10.2 Linkage ID (Conditional)
7.3.7.10.3 Linkage name (Conditional)
7.3.7.10.4 Residue site (Mandatory)
7.3.7.11 Reference source (Conditional)
7.3.7.11.1 Reference source document (Conditional)
7.3.8 Modification (Conditional)
7.3.9 Property (Conditional)
7.3.9.1 Amount (Mandatory)
7.3.9.1.1 Reference range (Conditional)
7.3.10 Molecular weight (Conditional)
7.3.10.1 Amount (Mandatory)
7.3.10.1.1 Reference range (Conditional)
7.3.11 Substance Name (Mandatory)
7.3.12 Substance Code (Conditional)
7.3.13 Version (Mandatory)
7.3.14 Reference information (Conditional)
7.3.15 Reference source (Conditional)
7.3.15.1 Reference source document (Conditional)
7.4 Polymers
7.4.1 Polymer class (Mandatory)
7.4.2 Polymer geometry (Mandatory)
7.4.3 Copolymer connectivity (Mandatory)
7.4.4 Comment (Optional)
7.4.5 Substance name (Mandatory)
7.4.6 Structure (Mandatory)
7.4.7 Monomer set description (Conditional)
7.4.7.1 Number of monomers (Mandatory)
7.4.7.2 Monomer amount type (Conditional)
7.4.7.3 Polymer Starting material (Conditional)
7.4.7.3.1 Starting material ID (Mandatory)
7.4.7.3.2 Starting material name (Mandatory)
7.4.7.3.3 Starting material type (Mandatory)
7.4.7.3.4 Is defining (Mandatory)
7.4.7.3.5 Amount (Conditional)
7.4.7.3.5.1 Reference range (Conditional)
7.4.8 Structural repeat (Mandatory)
7.4.8.1 Number of structural repeat units (Mandatory)
7.4.8.2 Average molecular formula by repeat unit (Conditional)
7.4.8.3 Structural repeat unit amount type (Conditional)
7.4.8.4 Structural repeat unit (Mandatory)
7.4.8.4.1 Orientation of polymerization (Mandatory)
7.4.8.4.2 Structural repeat unit (Mandatory)
7.4.8.4.3 Amount (Mandatory)
7.4.8.4.3.1 Reference range (Conditional)
7.4.8.4.4 Structural representation (Mandatory)
7.4.8.4.5 Degree of polymerization (Conditional)
7.4.8.4.5.1 Degree of polymerization (Mandatory)
7.4.8.4.5.2 Amount (Mandatory)
7.4.8.4.5.2.1 6.4.8.4.5.2.1 Reference range (Conditional)
7.4.9 Molecular weight (Conditional)
7.4.9.1 Amount (Mandatory)
7.4.9.1.1 Reference range (Conditional)
7.4.10 Property (Conditional)
7.4.10.1 Amount (Mandatory)
7.4.10.1.1 Reference range (Conditional)
7.4.11 Substance code (Conditional)
7.4.12 Version (Mandatory)
7.4.13 Reference information (Conditional)
7.4.14 Modification (Conditional)
7.4.15 Source material (Conditional)
7.4.16 Reference source (Conditional)
7.4.16.1.1 Reference source document (Conditional)
7.5 Structurally diverse substances
7.5.1 Comment (Optional)
7.5.2 Substance name (Mandatory)
7.5.3 Structure (Conditional)
7.5.4 Property (Conditional)
7.5.4.1 Amount (Mandatory)
7.5.4.1.1 Reference range (Conditional)
7.5.5 Molecular weight (Conditional)
7.5.5.1 Amount (Mandatory)
7.5.5.1.1 Reference range (Conditional)
7.5.6 SD glycosylation (Conditional)
7.5.6.1 SD glycosylation type (Conditional)
7.5.7 Modification (Conditional)
7.5.8 Source material (Mandatory)
7.5.9 Substance code (Conditional)
7.5.10 Reference information (Conditional)
7.5.11 Version (Mandatory)
7.5.12 Reference source (Conditional)
7.5.12.1 Reference source document (Conditional)
7.5.13 Herbals and substances used in the preparation of plant-based allergenic extracts
7.5.13.1 Naming vegetable oils
7.5.13.1.1 Example: Olive Oil, Virgin
7.5.14 Vaccines
7.5.15 Plasma-derived substance for human blood products and polyclonal antibodies
7.5.16 Allergens
7.5.17 Advanced Therapies and Advanced Vaccines (Genes, Modified Viruses, Cells and Tissues as Substances)
7.5.18 Minerals
7.6 Mixture
7.6.1 Mixture type (Mandatory)
7.6.2 Is multi-substance starting material (Mandatory)
7.6.3 Constituent component (Mandatory)
7.6.3.1 Constituent component ID (Mandatory)
7.6.3.2 Constituent component name (Mandatory)
7.6.3.3 Constituent component requirement (Mandatory)
7.6.3.4 Constituent component role (Conditional)
7.6.3.5 Amount (Conditional)
7.6.4 Multi-substance starting material property (Conditional)
7.6.4.1 Multi-substance property type (Conditional)
7.6.4.2 Multi-substance property name (Conditional)
7.6.4.3 Multi-substance property parameter (Conditional)
7.6.5 Modification (Conditional)
7.6.6 Source material (Conditional)
7.6.7 Substance name (Mandatory)
7.6.8 Substance code (Conditional)
7.6.9 Reference information (Conditional)
7.6.10 Version (Mandatory)
8 Specified substance (Conditional)
8.1 Specified Substance Group 1 (Conditional)
8.1.1 Specified substance Group 1 ID (Mandatory)
8.1.2 Substance name (Mandatory)
8.1.3 Substance Code (Conditional)
8.1.4 Version (Mandatory)
8.1.5 Reference source (Conditional)
8.1.5.1 Reference source document (Conditional)
8.1.6 Constituent (Conditional)
8.1.6.1 Constituent substance ID (Mandatory)
8.1.6.2 Contituent substance name (Mandatory)
8.1.6.3 Language (Conditional)
8.1.6.4 Substance role (Mandatory)
8.1.6.5 Is defining (Mandatory)
8.1.6.6 Amount (Conditional)
8.1.6.6.1 Reference range (Conditional)
8.1.7 Characteristic attribute (Conditional)
8.1.7.1 Attribute type (Mandatory)
8.1.7.2 Attribute name (Mandatory)
8.1.7.3 Attribute substance ID (Conditional)
8.1.7.4 Attribute substance name (Conditional)
8.1.7.5 Is defining (Mandatory)
8.1.7.6 Amount (Mandatory)
8.1.7.6.1 Reference range (Conditional)
8.1.7.7 Attribute parameter (Conditional)
8.1.7.7.1 Attribute parameter name (Mandatory)
8.1.7.7.2 Attribute parameter value (Mandantory)
8.1.7.7.3 Amount (Mandatory)
8.1.7.7.3.1 Reference range (Conditional)
8.1.8 Fraction description (Conditional)
8.1.8.1 Fraction (Conditional)
8.1.8.2 Material type (Conditional)
8.1.8.3 Reference Source (Conditional)
8.1.8.3.1 Reference source document (Conditional)
8.1.9 Modification (Conditional)
8.1.10 Reference Information (Conditional)
8.1.11 Physical form (Conditional)
8.1.11.1 Physical state (Mandatory)
8.1.11.2 Physical form type (Conditional)
8.1.11.3 Amount (Conditional)
8.1.11.3.1 Reference range (Conditional)
8.2 Specified substance Group 2 (Conditional)
8.2.1 Specified Substance Group 2 ID (Mandatory)
8.2.2 Substance Name (Mandatory)
8.2.3 Substance code (Conditional)
8.2.4 Reference source (Conditional)
8.2.4.1 Reference source document (Conditional)
8.2.5 Reference information (Conditional)
8.2.6 Version (Mandatory)
8.2.7 Manufacturing (Mandatory)
8.2.7.1 Manufacturing type (Conditional)
8.2.7.2 Production method type (Conditional)
8.2.7.3 Production method description (Conditional)
8.2.7.4 Production system type (Conditional)
8.2.7.5 Production system (Conditional)
8.2.7.6 Critical process version number (Conditional)
8.2.7.7 Version (Mandatory)
8.2.7.8 Version date (Mandatory)
8.2.7.9 Organization (Mandatory)
8.2.7.9.1 Manufacturer ID (Mandatory)
8.2.7.9.2 Manufacturer name (Mandatory)
8.2.7.9.3 Issuer of ID (Mandatory)
8.2.7.9.4 Manufacturer role (Mandatory)
8.3 Specified Substance Group 2 Extended (Conditional)
8.3.1 Specified Substance Group 2 ID (Mandatory)
8.3.2 Substance Name (Mandatory)
8.3.3 Substance code (Conditional)
8.3.4 Reference source (Conditional)
8.3.4.1 Reference source document (Conditional)
8.3.5 Reference information (Conditional)
8.3.6 Version (Mandatory)
8.3.7 Manufacturing (Mandatory)
8.3.7.1 Manufacturing type (Conditional)
8.3.7.2 Production method type (Conditional)
8.3.7.3 Production method description (Conditional)
8.3.7.4 Production system type (Conditional)
8.3.7.5 Production system (Conditional)
8.3.7.6 Critical process version number (Conditional)
8.3.7.7 Version (Mandatory)
8.3.7.8 Version date (Mandatory)
8.3.7.9 Organization (Mandatory)
8.3.7.10 Production step (Conditional)
8.3.7.10.1 Process site ID (Conditional)
8.3.7.10.2 Process site name (Conditional)
8.3.7.10.3 Step number (Conditional)
8.3.7.10.4 Geographical coordinates (Mandatory)
8.3.7.10.5 Starting material (Conditional)
8.3.7.10.5.1 Starting material type (Conditional)
8.3.7.10.5.2 Manufacturing material substance (Mandatory)
8.3.7.10.5.2.1 Manufacturing material substance ID (Mandatory)
8.3.7.10.5.2.2 Manufacturing material substance name (Mandatory)
8.3.7.10.5.2.3 Grade type (Conditional)
8.3.7.10.5.2.4 Amount (Conditional)
8.3.7.10.5.2.5 Reference range (Conditional)
8.3.7.10.6 Processing material (Conditional)
8.3.7.10.6.1 Processing material type (Conditional)
8.3.7.10.7 Resultant material (Mandatory)
8.3.7.10.7.1 Resultant material type (Mandatory)
8.3.7.10.7.2 Holding time (Conditional)
8.3.7.10.7.3 Storage conditions (Conditional)
8.3.7.10.7.3.1 7.3.7.10.7.3.1 Manufacturing material substance (Mandatory)
8.4 Specified Substance Group 3 (Conditional)
8.4.1 Specified Substance Group 3 ID (Mandatory)
8.4.2 Substance Name (Mandatory)
8.4.3 Grade (Mandatory)
8.4.3.1 Grade type (Mandatory)
8.4.3.2 Grade name (Mandatory)
8.4.4 Version (Mandatory)
8.4.5 Substance code (Conditional)
8.4.6 Reference information (Conditional)
8.4.7 Reference source (Conditional)
8.4.7.1 Reference source document (Conditional)
9 Description of the information modelling principles and practices
9.1 General considerations
9.2 Conceptual overview diagrams
9.3 Section high-level diagrams
9.4 Detailed diagrams
9.4.1 Relationships between classes
9.4.2 Notes
9.4.3 Attributes
9.4.4 Message exchange format
9.4.5 Conformance terminology and context as it relates to the ISO 11238 and ISO/TS 19844 exchange format
Annex A (normative)Choosing a Substance ID
A.1 General
A.2 Requesting a Substance ID and providing information
Annex B (informative)Chemical substance
B.1 Introduction
B.1.1 Molecular Weight, Moiety and Amount for stoichiometric chemical substances
B.1.2 Relations with other Element Groups (see Figure B.2)
B.1.2.1 Element Group: Moiety
B.1.2.2 Element Group: Substance Relationship
B.1.2.3 Requesting a Substance ID
B.2 Outline of Annex B
B.3 Scope
B.4 Terms and definitions
B.5 Chemical Substance subtypes and Mixture
B.5.1 Substance type, Chemical substance
B.5.1.1 Stoichiometric chemical substances
B.5.2 Solid state forms of the Substance
B.5.2.1 Co-crystals
B.5.2.2 Solvates and hydrates
B.5.3 Need to substantiate the chemical structure, molecular formula and molecular weight
B.5.4 Polymorphism
B.5.4.1 Example: Tibolone [C21H28O2]
B.5.5 Non-stoichiometric chemical substances
B.5.5.1 Example: USP monograph: Aluminium Chlorohydrex Propylene Glycol
B.5.5.2 Example: Octeotride Acetate
B.5.6 Mixture
B.5.6.1 Teicoplanin (Ph.Eur.)
B.5.7 Multi-substance material
B.5.7.1 Example: Paclitaxel-Albumin complex
B.6 Discussion of the key elements of a chemical substance
B.6.1 Identity of material
B.6.2 Nomenclature
B.6.3 Molecular formula
B.6.4 Molecular weight
B.6.5 Substance structure
B.6.5.1 Stereochemistry
B.6.5.2 General aspects of stereochemistry
B.6.6 Geometric isomerism
B.6.6.1 (E/Z) isomerism
B.6.6.2 Cis-Trans Ring-isomerism
B.6.7 Substance with two centres of Asymmetry, Epimers, Diastereomers
B.6.8 Anomers
B.6.9 Substance with more than two centres of Asymmetry (Mixture of stereoisomers)
B.6.10 Conclusion for the Key elements
B.6.11 Decision tree for a new Substance ID
B.7 Discussing other elements of importance regarding the characteristics of a substance
B.7.1 Introduction
B.7.2 Naming Vegetable Oils
B.7.3 Example Olive Oil, Virgin
B.7.4 Description of Elements at the Specified Substance Group 1 Information level
B.7.5 Description of Elements at the Specified Substance Group 2 Information level
B.7.6 Description of Elements at the Specified Substance Group 3 Information level
B.7.7 Olive Oil, Refined
B.7.8 Properties to be captured, related to liquids (vegetable oils)
B.7.8.1 Example: Identity of material, combining the elements for Olive Oil, Virgin (Ph.Eur.) and Olive Oil, Refined (Ph.Eur.)
B.7.9 Castor Oil and related products
B.7.9.1 Castor Oil, Virgin (Ph.Eur.)
B.7.9.2 Castor Oil, Hydrogenated (Ph.Eur.)
B.7.9.3 Explanation of the differences between Castor Oil, Virgin and Castor Oil, Hydrogenated
B.7.9.4 Castor Oil, Ethoxylated
B.7.10 Properties related to liquids (Gas), Nitrous oxide
B.8 Examples
B.8.1 Example 1: Amlodipine besilate
B.8.2 Example 2: Ponatinib hydrochloride
B.8.3 Example 3: Benzathine Benzylpenicillin tetrahydrate, sterilized.
B.9 Radiopharmaceutical substance
B.9.1 Introduction
B.9.2 Example: Florbetapir 18F
Annex C (normative)Protein substance
C.1 Introduction
C.2 Scope
C.3 Terms and definitions
C.4 Peptide Substances
C.4.1 Example: Vasopressin
C.4.2 Example IIIb: Desmopressin
C.4.3 Example: Desmopressin Acetate
C.4.4 Calcitonin Salmon
C.4.5 Example: Human Insulin
C.5 Element Group Protein, Specified Substance Group 1
C.5.1 Example: Insulin Human Zinc Suspension (Amorphous), taken from Ph.Eur./USP Monographs for Zinc Suspensions
C.5.2 Example: Insulin Human Zinc Suspension (Crystalline), taken from Ph.Eur./USP Monographs for Zinc Suspensions
C.5.3 Example: Insulin Human Zinc Suspension taken from Ph.Eur./USP Monographs for Zinc Suspensions, including discussion for Specified Substance Group 3 information
C.6 Element Group Protein, Specified Substance Group 2
C.6.1 Example: Synthetic Calcitonin Salmon-Manufacturer Company Acme
C.6.2 Example: Recombinant Calcitonin Salmon — Company Acme
C.7 Element Group Protein, Specified Substance Group 3
C.7.1 Example: Calcitonin Salmon (Synthetic) Specified Substance Group 3
C.7.2 Example: Calcitonin Salmon (Recombinant) Specified Substance Group 3
C.8 Example Protein Substance: Monoclonal Antibody Conjugated Toxin
C.9 Addendum: Microheterogeneity
C.9.1 Microheterogeneity
C.9.2 Introduction
C.9.3 Brentuximab Glycans
C.9.4 Structuring Monoclonal Glycans at the Specified Substance Information level
C.9.5 Example: Brentuximab Vedotin –Company XYZ.
C.9.6 Brentuximab Vedotin–In-house Grade.
Annex D (informative)Nucleic acid substance
D.1 Introduction
D.2 Scope
D.3 Terms and definitions
D.4 Examples
D.4.1 Example: 5-Methylcytosine
D.4.2 Example: A 5’-phosphate ribonucleotide
D.4.3 Residues involved in the internucleotide linkage.
D.5 Substances
D.5.1 Example: Mipomersen sodium information
D.5.2 Oligonucleotide Elements
D.5.2.1 Example Nucleic Acid Substance: Mipomersen sodium
D.5.2.2 Example: Nucleic Acid Substance: Litenimod
D.5.2.3 Example: Anti-sense RNA
Annex E (normative)Structurally Diverse Substance — Herbal Substance/Herbal Specified Substance
E.1 Scope
E.2 Introduction
E.2.1 Structurally Diverse Substance type
E.2.2 Organism Taxonomy
E.2.3 Substance Names
E.2.3.1 Substance (fresh) Name
E.2.3.2 Substance (Herbal Drug)
E.2.3.3 Substance (Herbal preparation)
E.2.4 Examples of Substance (fresh) and Substance (Herbal Drug) Names
E.2.5 Specified Substance Group 1, 2 and 3 information
E.2.5.1 Specified Substance Group 1 Name:
E.2.5.2 Specified Substance Group 2 Name:
E.2.5.3 Specified Substance Group 3 Name
E.2.5.4 Overview of the Naming connections of the Botanical Material for the Substance and Specified Substance Group 1, 2, 3 Levels
E.2.6 Specified Substance Group 1 Information
E.2.7 Specified Substance Group 2 Information
E.2.8 Substance and Specified Substance information for Iberis amara L, Whole Plant and of the liquid extract. (Simplified example)
E.2.9 Specified Substance Group 2 Information for Iberis amara, Whole Plant, liquid extract (Extended Information)
E.2.10 Specified Substance Group 3 Information
E.3 Terms and definitions
E.3.1 Definitions according to Directive 2001/83/EC and Directive 2004/24/EC, Title 1, Definitions
E.3.2 Definitions according to the European Pharmacopoeia
E.4 Documentation and Explanation of Example 1
E.4.1 Example Ginkgo biloba, leaf taken from the European Pharmacopoeia
E.4.2 Herbal preparation Ginkgo biloba extract, Limited information: Description of the elements at the Substance information level
E.4.2.1 Herbal preparation Ginkgo biloba extract, Limited information: Description of the elements at the Specified Substance Group 1, 2 and 3.
E.4.2.2 Herbal preparation Ginkgo biloba extract, Extended information: Description of the elements at the Specified Substance Group 1, 2 and 3.
E.4.3 Example 2: Devil’s Claw Root (Ph.Eur.), continued
E.4.3.1 General Information Herbal Drug
E.4.3.2 General Information Herbal preparation
E.4.4 Organization of the information according to ISO 11238 and ISO/TS 19844
E.4.4.1 Information at the Substance level
E.4.4.2 Substance (Fresh)
E.4.4.3 Substance (Usually Dry, may be Fresh as described in a Pharmacopoeia) = Herbal Drug
E.4.4.4 Substance, Herbal preparation
E.4.4.5 Specified Substance Group 1 information level for the Herbal Drug
E.4.4.6 Specified Substance Group 2 information level for the Herbal Drug
E.4.4.7 Specified Substance Group 3 information level for the Herbal Drug
E.4.4.8 Elements captured at the Specified Substance Group 1 level for the Herbal preparation (Extract, extended information)
E.4.4.9 Elements captured at the Specified Substance Group 2 level for the Herbal preparation (Extract, extended information)
E.4.4.10 Elements captured at the Specified Substance Group 3 level for the Herbal preparation (Extract, extended information)
E.4.5 Summary of the Organization of the information for Devil’s Claw
E.5 Documentation and Explanation of Example 3
E.5.1 Example 3: Salvia Miltiorrhiza Root and Rhizome (BP=Ph.Eur.) and Chinese Salvia (USP), continued.
E.5.1.1 Specifications according to the USP and Ph.Eur.:
E.5.1.2 Submitted Data
E.5.2 Herbal preparation: Salvia Miltiorrhiza Extract provided information
E.5.3 Organization of the information according to ISO 11238 and ISO/TS 19844
E.5.3.1 Substance information level
E.5.3.1.1 Substance (fresh)
E.5.3.1.2 Substance (Herbal Drug)
E.5.3.1.3 Substance (Herbal preparation)
E.5.3.2 Specified Substance Group 1 information level (Herbal Drug)
E.5.3.3 Specified Substance Group 2 information level (Herbal Drug)
E.5.3.4 Specified Substance Group 3 information level (Herbal Drug)
E.5.4 Specified Substance Group 1 information level of Herbal preparation (Extract, extended information)
E.5.4.1 Specified Substance Group 2 information level of the Herbal preparation (Extract, extended information)
E.5.4.2 Specified Substance Group 3 information level (Herbal preparation)
E.6 Documentation and Explanation of Example 4
E.6.1 Herbal preparations Olive Oil, Virgin (Ph.Eur.) and Olive Oil, Refined (Ph.Eur.)
E.6.1.1 Olive Oil, Virgin (Ph.Eur.)
E.6.1.2 Elements to be described at the Substance (fresh) and Substance (Herbal preparation) level
E.6.1.3 Elements to be described at the Specified Substance Group 3 Information level (Herbal preparation).
E.7 Documentation and Explanation of Example 5
E.7.1 JP XVI monograph Shakuyakukanzoto Extract, see Figure E.38.
E.7.2 JP Monograph for Preparations Related to Crude Drugs, I. Extract
E.7.3 JP Monograph of the Crude Drugs (starting materials) JP monograph Peony Root and Glycyrrhiza
E.7.4 Organization of the information in accordance to ISO 11238 and ISO/TS 19844
E.7.4.1 Information captured at the Substance level for Glycyrrhiza (JP)
E.7.4.2 Substance (Fresh)
E.7.4.2.1 Substance (Fresh)
E.7.4.3 Substance (Herbal Drug)
E.7.4.4 Information captured at the Group 1 Specified Substance level for the Herbal Drug Glycyrrhiza (JP)
E.7.4.5 Information captured at the Substance level for Peony Root (JP)
E.7.4.6 Information captured at the Substance level for Peony Root (JP)
E.7.4.7 Information captured at the Group 1 Specified Substance level for the Herbal Drug Peony Root (JP)
E.7.4.8 Information captured at the Substance level for the Herbal preparation Shakuyakukanzoto Extract
E.7.4.9 Information captured at the Group 1 Specified Substance level for Shakuyakukanzoto Extract (JP)
E.7.4.10 Information captured at the Specified Substance Group 2 level for Shakuyakukanzoto Extract (JP)
E.7.4.11 Information captured at the Group 3 Specified Substance level for Shakuyakukanzoto Extract (JP)
E.8 General Information on the use of Glycyrrhiza species and their constituents
E.8.1 Herbal preparation, Liquorice extract
E.9 Exudates
E.9.1 Examples
E.9.1.1 Peru balsam, Ph.Eur. monograph 01/2008:0754
E.9.1.2 Production of Peru Balsam
E.9.1.3 Tolu balsam, Ph.Eur. monograph 01/2008:1596
E.9.1.4 Production of Tolu Balsam
E.9.2 Conclusion
E.10 Peru Balsam/Tolu Balsam structuring information
E.10.1 Capturing information for Peru Balsam (Ph.Eur.) at the Substance information level
E.10.1.1 Substance (Fresh)
E.10.1.2 Substance (Herbal preparation)
E.10.2 Capturing information for Peru Balsam (Ph.Eur.) at the Specified Substance information level
E.10.2.1 Element Group: Specified Substance Group 1
E.10.2.2 Element Group: Specified Substance Group 2
E.10.2.3 Element Group: Specified Substance Group 3
E.10.3 Capturing information for Tolu Balsam (Ph.Eur.)
E.10.3.1 Substance (Fresh)
E.10.3.2 Substance (Herbal preparation)
E.10.4 Specified Substance information level
E.10.4.1 Element Group: Specified Substance Group 1
E.10.4.2 Element Group: Specified Substance Group 2
E.11 Comparison table
Annex F (informative)Structurally Diverse Substance, Homeopathic substance
F.1 Introduction
F.1.1 Introduction
F.1.2 Homeopathy and the use of homeopathic medicinal products
F.1.3 Legislation and regulatory requirements
F.2 Manufacturing of homeopathic medicinal products/homeopathic references
F.2.1 Legislation and regulatory requirements
F.3 Specific Definitions of Homeopathic Manufacturing
F.3.1 Homeopathic Stocks
F.3.2 Homeopathic preparation
F.3.3 Homeopathic Dilutions
F.3.3.1 Decimal dilution/decimal potencies
F.3.3.2 Centesimal dilution/centesimal potencies
F.3.3.3 LM – potencies
F.3.3.4 Korsakovian potencies
F.3.3.5 Methods of preparation of homeopathic stocks and potentization
F.3.3.6 Mother Tincture
F.3.3.7 Nosode
F.3.3.8 Potentization
F.3.3.9 Raw material
F.3.3.10 Succussion
F.3.3.11 Vehicle
F.3.4 Dosage Forms
F.3.5 Homeopathic Stocks and Raw Materials
F.3.6 Classification of Homeopathic Stocks and Homeopathic Dilutions (in accordance with ISO 11238 and ISO/TS 19844)
F.3.6.1 Homeopathic starting material
F.3.6.2 Capturing Information at the Specified Substance Group 1 information level
F.3.6.3 Substance Dilution Potentization
F.3.6.3.1 Decimal dilution/decimal potencies
F.3.6.3.2 Centesimal dilution/centesimal potencies
F.3.6.3.3 LM – potencies
F.3.6.4 Vehicle
F.3.6.5 Organism Taxonomy of Structural Diverse Substance Type, e.g. Herbal and Zoological Organism
F.3.7 Capturing of the Homeopathic medicine (Stock. Dilution Grade, Dilution method)
F.3.7.1 Substance information level: (Homeopathic Substance)
F.3.7.2 Specified Substance Group 1: (Herbal)
F.3.7.3 Specified Substance Group 2
F.3.7.4 Specified Substance Group 3:
F.3.8 Nomenclature of Homeopathic Medicines
F.3.9 Nomenclature of Homeopathic Medicines
F.3.10 Nomenclature according to homeopathic tradition
F.3.11 Nomenclature according to homeopathic tradition
F.4 Examples in tabular format
F.4.1 Structured information of material combining the elements for Arnica montana 6DH, Substance of botanical origin according to the French tradition
F.4.2 Structured information of material, combining the elements for Arnica montana D6, Substance of botanical origin according to the German tradition
F.4.3 Structured information of material, combining the elements for Arsenicum album C30 Substance of chemical origin according to the German tradition
F.4.4 Structured information of material, combining the elements for Lachesis 200K, Substance of zoological origin according to the Korsakovian dilution method
F.4.5 Structured Information of material, combining the elements for Pyrit D2, Substance of mineral origin according to the German tradition.
Annex G (informative)Structurally Diverse Substance — Plasma-derived substances
G.1 Scope
G.2 General Aspects of Plasma-derived Substances
G.2.1 Source material
G.2.2 Manufacturing process
G.2.3 Adventitious agents
G.2.4 Substance classification for plasma-derived products
G.2.4.1 General Remarks
G.2.4.2 Manufacturing plasma pool/Plasma for fractionation (Ph.Eur. monograph 0853)
G.2.4.3 Cryoprecipitate and Cryopoor plasma
G.2.4.4 Plasma-derived substance
G.3 Terms and definitions
G.4 Structuring the required information
G.4.1 Substance information level
G.4.2 Country of plasma origin
G.4.3 Reference Source and Reference Source Document
G.4.4 Testing strategy
G.4.5 Summary of the information regarding Cryoprecipitate and Cryopoor plasma
G.4.6 Substance information example for a plasma-derived Substance/product ‘Human Albumin, Plasma-derived', Part 1: Cryopoor plasma
G.4.7 Specified Substance Group 1 Information level
G.4.8 Summary
G.4.9 Specified Substance Group 2 Information level
G.4.10 Structuring of the plasma-derived substance information
G.4.10.1 Substance Information level
G.4.10.2 Specified Substance Group 2 Information level
G.4.10.3 Specified Substance Group 3 Information level: specifications
G.4.11 Virus Risk Assessment
G.5 Example Plasma-derived Factor VIII + VWF
G.5.1 Introduction/background information for FVIII example
G.5.2 General discussion of the structure of FVIII
G.5.2.1 Molecular characterization of FVIII
G.5.2.2 Tabular information of the FVIII example at the Substance information level
G.5.2.3 Information of the FVIII example at the Specified Substance Group 2 information level
Annex H (normative)Polymer substance
H.1 Introduction
H.2 Scope
H.3 Terms and definitions
H.4 Data elements
H.4.1 Polymer Class
H.4.2 Polymer Geometry
H.4.3 Copolymer connectivity
H.4.4 Structural Repeat Unit (SRU)
H.4.5 Degree of Polymerization
H.4.6 Monomers, Polymer starting material
H.4.7 Molecular Weight
H.4.8 Property
H.4.9 Modification
H.4.10 Source Material
H.5 Linear Synthetic Polymers
H.5.1 Example1: Polyethylene Glycol 3350
H.6 Modified Linear Polymers
H.6.1 Example 2: Hypromellose 2910 (4000 mPa.s)
H.7 Linear Block Copolymers
H.7.1 Example 3: Poloxamer 338
H.7.2 Poloxamer 338 Specified Substance Group 2 information Level
H.7.3 Poloxamer Specified Substance Group 3
H.8 Linear Biologically Sourced Polymers
H.8.1 Glycosaminoglycans
H.8.2 Heparins
H.8.3 Example 4: Heparin Sodium
H.9 Nucleic Acids
H.9.1 Defibrotide (Porcine)
Annex I (informative)Structurally diverse vaccines
I.1 Scope
I.2 Introduction
I.2.1 Introduction
I.2.2 Types of Vaccines Antigens
I.2.3 Strategy for Defining Vaccines
I.2.4 Recombinant Proteins
I.3 Terms and definitions
I.4 Example: Hepatitis B vaccines
I.4.1 Background information of Hepatitis B S protein
I.4.2 Development of hepatitis B vaccine from transformed yeast cells
I.4.3 Capturing information for Hepatitis B Surface Antigen Virus-like particles produced in yeast cells
I.4.4 Capturing manufacturing information for Hepatitis B Surface Antigen Virus-like particles produced in yeast cells
I.4.5 Capturing manufacturing information for Hepatitis B Surface Antigen Virus-like particles produced in yeast cells
I.5 Example: Live attenuated Vaccines, BCG vaccine, Freeze-dried and BCG for immunotherapy
I.5.1 General information about the BCG strain
I.5.2 Capturing information for a live attenuated vaccine following the Structurally diverse content data model
I.5.3 Substance Name of the Source Material
I.5.4 Strain history and population doublings, general information
I.5.5 Specified Substance Group 1 Information
I.5.6 Information of the BCG-strain: Danish 1331 strain MS and Working seed.
I.6 Bacterial vaccine, inactivated antigen and conjugated to a carrier protein
I.6.1 Definition as described in the Ph. Eur Meningococcal group ACWY Vaccine monograph 01/2008:0250
I.6.2 Description of the substances comprised in Men(ACWY)
I.6.2.1 MenA Polysaccharide and Oligosaccharide Description
I.6.2.2 MenC Polysaccharide and Oligosaccharide Description
I.6.2.3 MenW Polysaccharide and Oligosaccharide Description
I.6.2.4 MenY Polysaccharide and Oligosaccharide Description
I.6.2.5 Requirements as described in the Ph. Eur Meningococcal group ACWY Vaccine monograph 01/2008:0250
I.6.2.5.1 Production
I.6.2.5.2 Seed Lots
I.6.2.5.3 Propagation and Harvest
I.6.3 History of the strain
I.6.3.1 Taxonomic information
I.6.3.2 Master Seed
I.6.3.3 Working Seed
I.6.3.4 Propagation and Harvesting
I.6.3.5 Downstream Purification of the Crude Polysaccharides
I.6.4 Coupling to a Carrier Protein
I.6.5 CRM197 Coupling mechanism to polysaccharides
I.6.6 Requirements of the Degree of Polymerization [78]
I.6.7 New strategies concerning type coupling and type of glycan structure conjugates
I.6.8 Registration of CRM197
I.6.9 Capturing the information of Meningococcal conjugated vaccine according to ISO/TS 19844
I.7 Tabular information for CRM197
I.7.1 Specified Substance Group 1 Information for Corynebacterium diphtheriae CRM197 protein
I.7.2 Specified Substance Group 2 Information for Corynebacterium diphtheriae CRM197 protein
I.7.3 Specified Substance Group 3 Information for Corynebacterium diphtheriae CRM197 protein
I.8 Tabular information for Meningococcal ACWY conjugate vaccine
I.8.1 Registration of Tabular Information N. meningitidis group A oligosaccharide conjugated to CRM197 protein
I.8.2 Specified Substance Group 1 Information for N. Meningitidis group A polysaccharide
I.8.3 Specified Substance Group 2 Information for N. Meningitidis group A polysaccharide
I.8.4 Specified Substance Group 3 Information for N. Meningitidis group A polysaccharide
I.8.5 Substance Information for N. Meningitidis group A oligosaccharide conjugated to CRM197 protein
I.9 Registration of Tabular Information N. meningitidis group C oligosaccharide conjugated to CRM197 protein
I.9.1 Registration of N. meningitidis group C polysaccharide
I.9.2 Specified Substance Group 1 Information for N. Meningitidis group C polysaccharide
I.9.3 Specified Substance Group 2 Information for N. Meningitidis group C polysaccharide
I.9.4 Specified Substance Group 3 Information for N. Meningitidis group C polysaccharide
I.9.5 Substance Information for N. Meningitidis group C oligosaccharide conjugated to CRM197
I.10 Registration of Tabular Information N. meningitidis group W oligosaccharide conjugated to CRM197 protein
I.10.1 Registration of N. meningitidis group W polysaccharide
I.10.2 Specified Substance Group 1 Information for N. Meningitidis group W polysaccharide
I.10.3 Specified Substance Group 2 Information for N. Meningitidis group W135 polysaccharide
I.10.4 Specified Substance Group 3 Information for N. Meningitidis group C W135 polysaccharide
I.10.5 Substance Information for N. Meningitidis group W135 oligosaccharide conjugated to CRM197 protein
I.11 Registration of Tabular Information N. meningitidis group Y oligosaccharide conjugated to CRM197 protein
I.11.1 Registration of N. meningitidis group Y polysaccharide
I.11.2 Specified Substance Group 1 Information for information Neisseria Meningitidis group Y polysaccharide
I.11.3 Specified Substance Group 2 Information for Neisseria Meningitidis group Y polysaccharide
I.11.4 Specified Substance Group 3 Information for Neisseria Meningitidis group Y polysaccharide
I.11.5 Substance Information for Neisseria Meningitidis group Y oligosaccharide conjugated to CRM197
I.12 Influenza vaccines
I.12.1 Influenza vaccines, International requirements
I.12.2 Influenza vaccines, Haemagglutinin and Neuramidase antigens
I.12.3 Influenza vaccines Nomenclature
I.12.4 Manufacture of a split vaccine
I.12.5 Information to be captured in accordance to ISO 11238 and ISO/TS 19844
I.12.6 Substance Name
I.12.7 Specified Substance Group 1 Information for Influenza A virus A/California/7/2009 (H1N1) pdm09-like virus used A/Christchurch/16/2010 (H1N1), NIB-74xp
I.12.8 Specified Substance Group 2 Information for Influenza A virus A/California/7/2009 (H1N1) pdm09-like virus used A/Christchurch/16/2010 (H1N1), NIB-74xp
Annex J (informative)Structurally diverse allergen substances
J.1 Introduction
J.2 Scope
J.3 Terms and definitions
J.4 General aspects of allergen substances
J.4.1 Allergens and allergies
J.4.2 Source material
J.5 Characterization of the allergen preparation
J.5.1 In-house reference preparation
J.5.2 Identification
J.5.3 Tests and properties
J.6 Characterization of the Major allergens in an allergen preparation
J.6.1 Example 1: Identification of Major allergens in House dust mite (HDM).
J.6.1.1 Introduction
J.6.1.2 Group 1 Allergens, structure information
J.6.1.3 Group 2 Allergens, structure information
J.6.2 Description of the Allergenic Substance in a standardized allergen extract of HDM
J.6.2.1 Composition of Allergenic Substances in the HDM SLIT-tablet
J.6.2.2 Isolation of the Group 1 and Group 2 allergens from the source material
J.6.2.3 Structuring the Source Material information according to ISO 11238 and ISO/TS 19844.
J.6.2.4 Summary of organization the Substance and Specified Substance information for the Dermatophagoides species, without modification.
J.7 Example Grass pollens (modified)
J.7.1 Introduction to the grass pollen extract
J.7.2 Organization of the grass pollen extract in accordance to the ISO content data models
Annex K (informative)Advanced therapies and advanced vaccines(genes, modified viruses, cells and tissues as substances) (placeholder)
K.1 Scope
K.2 Introduction
K.3 Substances in Advanced Therapies
K.3.1 Genes
K.3.2 Silencing genes
K.3.2.1 Anti-sense oligonucleotides
K.3.2.2 Si-RNA
K.3.3 Gene therapy products
K.3.3.1 Naked, complexed or liposomal DNA
K.3.3.2 Transducing viral vectors
K.3.3.3 Gene modified Cells
K.3.3.4 Genetically modified bacteria
K.3.3.5 Zincfinger CRISPR-cas
K.3.4 Cell therapy products
K.3.4.1 Stem and progenitor cells
K.3.4.2 Differentiated cells
K.3.4.3 Antigen primed cells
K.3.5 Tissue engineered products and engineered tissues
K.3.5.1 Tissue engineered products
K.3.5.2 Scaffolds and decellularized matrices
K.3.5.3 Engineered tissues
K.4 Substances in Advanced Vaccines against infectious diseases
K.4.1 Nucleic acid vaccines
K.4.2 Recombinant viruses
Bibliography