Hygiene Tests - 20220420
Pawel Garbacz
Owned by Pawel Garbacz
Jul 22, 2024
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Source
The tests were applied to commit6d6a047.
Outstanding Errors:
ERROR:https://purl.iso.org/idmp/MandatoryInformation is referenced by conformance but has no type.
ERROR:https://spec.edmcouncil.org/idmp/ontology/ISO/ISO11240-IdentificationAndExchangeOfUnitsOfMeasurement/hasLanguageCode is referenced by onProperty but has no type.
All Issues
Issues in PROD Expand source
- Running test : [Deprecated resources should not be used.] warning,resource WARN: Deprecated resource https://www.omg.org/spec/LCC/Countries/ISO3166-1-CountryCodes/Macedonia is still in use.,https://www.omg.org/spec/LCC/Countries/ISO3166-1-CountryCodes/Macedonia
Issues in DEV Expand source
======================================= Errors in DEV:
- Running test : [Classes should not refer to multiple concepts.]
- Running test : [Count of OWL classes]
info,count
INFO: count of OWL classes,525
- Running test : [Labels should be unique across all ontologies for classes and properties.]
WARN: 'compression algorithm' labels multiple objects.,https://spec.edmcouncil.org/idmp/ontology/ISO/ISO21090-HarmonizedDatatypes/IntegrityCheckAlgorithm,http://www.w3.org/2002/07/owl#Class
WARN: 'compression algorithm' labels multiple objects.,https://spec.edmcouncil.org/idmp/ontology/ISO/ISO21090-HarmonizedDatatypes/CompressionAlgorithm,http://www.w3.org/2002/07/owl#Class
WARN: 'has control information root' labels multiple objects.,https://spec.edmcouncil.org/idmp/ontology/ISO/ISO21090-HarmonizedDatatypes/hasControlInformationRoot,http://www.w3.org/2002/07/owl#DatatypeProperty
WARN: 'has control information root' labels multiple objects.,https://spec.edmcouncil.org/idmp/ontology/ISO/ISO21090-HarmonizedDatatypes/hasControlInformationExtension,http://www.w3.org/2002/07/owl#DatatypeProperty
- Running test : [We should avoid punning object and datatype properties]
- Running test : [Object properties shouldn't have more than one inverse.]
- Running test : [Definitions shouldn't be circular - this finds direct circularities therein.]
WARN: Definition of https://spec.edmcouncil.org/idmp/ontology/ISO/ISO21090-HarmonizedDatatypes/CompressionAlgorithm is immediately circular ,"code element that identifies a compression algorithm, if any, used on the raw byte data",compression algorithm
- Running test : [We should avoid punning object and datatype properties]
- Running test : [Text should not use special characters]
WARN: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 has a bad character |——| for property http://purl.org/dc/terms/title
WARN:The identifier of the paternal species constituting the hybrid organism should be specified based on a controlled vocabulary.
For plants, the parents aren’t always known, and it is unlikely that it will be known which is maternal and which is paternal. has a bad character |’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:Lysine; non-specific modifications; Reducing end of Oligosaccharide; ε-amino, α-amino, guanidinyl, secondary amino, and hydroxyl groups (in decreasing order of reactivity) of amino acids residues of proteins. has a bad character |εα| for property http://www.w3.org/2004/02/skos/core#example"
WARN:For each substance type, a qualification is possible, e.g. Structuraly Diverse (Plasma-derived), Structurally Diverse (Herbal Substance), Structurally Diverse (Herbal Drug), Structurally Diverse (Allergen Substance), Polymer (Biopolymer), Protein (Recombinant), Protein (Naturally-derived), Protein (Allergen, Naturally-derived), Chemical (Mineral, naturally occurring substance), Mixture (Homologous Group of Allergen Source Material), etc. In these cases, the qualifier shall also be captured at the Substance Name Type attribute described in and shall always coupled with the substance name.
Example:
Substance Type: Structurally Diverse
Substance Name Type: Plasma-derived
Substance Name: Human Albumin, Plasma-derived (see also )
In all these cases, a new ID shall be issued, that is, `Human Albumin, Plasma-derived` shall have a distinct identifier from `Human Albumin, Recombinant`. has a bad character |````| for property https://purl.iso.org/idmp/businessRules"
WARN:For Viscosity, solvent concentration and temperature should be captured as a single entity.
Measured at pH range of 2,5 to 10,5.
Measured at 20°C and a pH of 7,1. has a bad character |°| for property http://www.w3.org/2004/02/skos/core#example"
WARN:Designation of which authority assigned the Offficial Name of the Substance or Specified Substance. All official names need to have at least one such designation. The name type is the name of the authority or authorities that have assigned or have adopted the name.
Any authority which assigns official names shall typically do so in a publication, and as such, referencing the publication is sufficient indication for the name being “official” and sufficient representation for the “official name type”. When new official names are issued by official naming bodies, the naming bodies will be reflected in this terminology. has a bad character |“”“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The attribute ‘Specification Category’ is a controlled vocabulary with the values: ‘Identity’, ‘Impurity’, ‘Potency’ and ‘Other’.
‘Identification’ describes a specification to establish the identity of the (new) drug substance. The method should be able to discriminate between compounds of closely related structure which are likely to be present. Identity tests should be specific for the (new) drug substance, e.g. infrared spectroscopy, the use of two chromatographic procedures, where the separation is based on different principles, or combination of tests into a single procedure, such as HPLC/UV diode array, HPLC/MS, or GC/MS, is generally acceptable.
Under the specification category ‘Other’ values are grouped like Heavy Metals, Loss on Drying, Appearance, pH, Residual solvents and Water content etc.
‘Appearance’ describes a qualitative description of the substance (e.g., solid state form, size, shape, and colour). If any of these characteristics change during manufacture or storage, this change should be investigated and appropriate action taken. The acceptance criteria should include the final acceptable appearance.
The attribute Specification ‘Type’ has the values: Chemical test, Physical test, Bioassay, Assay, Relative UV absorption (UV 254 nm /UV280 nm), In process specification and Re-test specification etc.
The element groups ‘Identity’, ‘Potency’ and ‘Other’ shall capture information about the identity, potency and appearance of a substance since at least one identity test, potency test and description of the substance shall be provided in accordance with the ICH Topic Q 6 A, 3.2.1 New drug substances. has a bad character |‘’‘’‘’‘’‘’‘’‘’‘’‘’‘’‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:NOTE 1 Another example of an identification specification is the molar (decadic) absorption coefficient or the molar extinction coefficient. The value for caffeine in water is: ɛmax λ = 272 nm = 1 115 m2 mol-1[24].
NOTE 2 The particle size (specification) is captured as a characteristic attribute in combination with the amount group as was earlier described at the Specified Substance Group 1 information level. So ‘particle size’ is not included in the value list of the attribute Category and thus, the class ‘Other’ is not applicable. has a bad character |ɛλ‘’‘’| for property http://www.w3.org/2004/02/skos/core#note"
WARN:If a unique “Specified Substance ID” has been assigned, this “Specified Substance ID” is specified based on the Substance Name controlled vocabulary.
In the absence of a unique “Specified Substance ID” e.g. for the initial submission of the substance this data element is not required. has a bad character |“”“”“”| for property http://www.w3.org/2004/02/skos/core#note"
WARN:The numeric value shall be always ≥2; The value is automatically calculated (Implicit) based on the number of Moieties as described in ); if the numeric value is equal to 1, the class Moiety shall not be used. has a bad character |≥| for property https://purl.iso.org/idmp/businessRules"
WARN:For each substance type, a qualification is possible, e.g. Structuraly Diverse (Plasma-derived), Structurally Diverse (Herbal Substance), Structurally Diverse (Herbal Drug), Structurally Diverse (Allergen Substance), Polymer (Biopolymer), Protein (Recombinant), Protein (Naturally-derived), Protein (Allergen, Naturally-derived), Chemical (Mineral, naturally occurring substance), Mixture (Homologous Group of Allergen Source Material), etc. In these cases, the qualifier shall also be captured at the Substance Name Type attribute described in and shall always coupled with the substance name.
Example:
Substance Type: Structurally Diverse
Substance Name Type: Plasma-derived
Substance Name: Human Albumin, Plasma-derived (see also )
In all these cases, a new ID shall be issued, that is, `Human Albumin, Plasma-derived` shall have a distinct identifier from `Human Albumin, Recombinant`. has a bad character |````| for property https://purl.iso.org/idmp/businessRules"
WARN:oils; juice; exudates; liquid or dry extract; polyclonal antibodies; serum; Cryopoor plasma; Cryoprecipitate, faecal fraction, body fraction; water soluble freeze-dried extract; water soluble extract; process flow ‘N’ has a bad character |‘’| for property http://www.w3.org/2004/02/skos/core#example"
WARN:Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement has a bad character |——| for property http://purl.org/dc/terms/title
WARN:Figure 38 provides the information to capture the grade of a substance. This group is meant to be for Pharmacopoeial Grades (Ph.Eur., USP). Each grade will lead for a separate Specified Substance Group 3 Identifier. However, there are applications in which regulatory approval has been achieved for more than one grade and sometimes the sponsor will add an extra specification, such as particle size which is not captured in the Pharmacopoeial monograph. In this case the model provides in the Reference documentation type “In-House” Grade in which a specification set can be laid down covering the Ph.Eur., USP as well as the intended particle size. has a bad character |“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The general model 'Substance – Specified Substance' as presented in Figure 1 allows to connect a Specified Substance Group 2 to Specified Substance Group 3. There are many examples in which an In-house specification is provided for a given substance tied to a specific manufacturer. This In-house specification might be covering the Ph.Eur. but is tightened. So the grade (Ph. Eur. or USP) is provided and an In-house specification which makes it necessary to connect a Specified Substance Group 2 to a Specified Substance Group 3. has a bad character |–| for property http://www.w3.org/2004/02/skos/core#note
WARN:A protein consists of a defined sequence of alpha-amino acids connected through peptide bonds folded into 3-dimensional structures and consists of one or more chains where each chain is a separate sub-unit.
Proteins that differ in protein sequence, type of glycosylation, disulfide linkages or glycosylation site shall be defined as separate substances. Detailed information on Glycosylation including the types of glycans and the extent of site of occupancy can be captured at the Specified Substance Group 1 information level.
The structural representation, the molecular formula, and the molecular weight are mandatory elements to be provided for non-glycosylated peptides and small proteins. These elements are inherited from the element groups ‘Structure’ and ‘Structural Representation’. The element group ‘Molecular Weight’ is part of the Protein class information model. See Figure 20. For all proteins, the molecular weight or molecular weight range should be provided, if known. Multiple molecular weights that either depend on the method or type should also be provided.
All non-glycosylated proteins shall be defined without regard to the method of synthesis, the cell line or organism biological matrix from which the protein was produced or isolated.
Proteins shall be described without regard to microheterogeneity.
Like chemical substances, protein substances and nucleic acid substances (described in 7.5) shall be described as single defined molecular entities. Microheterogeneity shall not be described because of inherent variability. Cyclic peptides and those derived largely from non-proteogenic amino acids as well as extensively-modified oligonucleotides shall be defined as chemical substances.
The type of glycosylation shall reflect significant differences in overall glycosylation and is determined from the species of the cell or tissue from which the protein was isolated. A limited set of controlled terminologies shall be used to describe the type of glycosylation.
Proteins shall be defined by the final expressed sequence; pre-pro-proteins and pro-proteins shall not be described.
Proteins that are irreversibly modified by either chemical or physical processes shall be defined as different proteins.
The description of modified proteins shall capture structural changes that result from the modification when a definitive structure is known.
Structural modifications shall be described using either moieties or molecular fragments that are added to the protein structure or by a description of the modification process if a definitive structural modification does not occur.
The molecular fragment or moiety may have a functional role and that role shall be captured using controlled terminology.
For specific modifications, the site and residue modified shall be described. When the site or sites are not definite the amino acid residue or residues modified will be captured along with the overall extent of modification.
Post-translational modifications shall only be captured if they are essential for activity or present on the predominant forms of the proteins.
In some instances, the modification will not result in a definitive structure. In these instances, the modification process shall be described in a minimal manner, capturing the modifying agent or physical conditions that result in an irreversible change.
Purified blood, or tissue materials whose putative functionality is attributed to a protein or a limited number of proteins with distinct and known amino acid sequences, shall be described as a protein.
Non-covalent interactions between proteins or peptide chains shall not be captured, with the exception of protein chains that are tightly associated with well-defined composition stoichiometry.
Non-defining elements as described below can also be captured at the substance level or/and Specified Substance Group 1 information level using the reference information model, see Figure 16:
— ligand, substrate or target;
— type of interaction of the protein;
— gene from which the protein was derived.
Reference information shall be captured using controlled vocabularies where available. has a bad character |‘’‘’‘’———| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:If a unique “Specified Substance ID” has been assigned, this “Specified Substance ID” is specified based on the Substance Name controlled vocabulary.
In the absence of a unique “Specified Substance ID” e.g. for the initial submission of the substance this data element is not required.
The Specified Substance ID is NOT SPECIFIED for Specified Substance ID Request. has a bad character |“”“”“”| for property http://www.w3.org/2004/02/skos/core#note"
WARN:Ethylene Oxide; .BETA.-D-Glucopyranose; Propylene Oxide; .BETA.-L-Iduronic acid, Pyranose form; Deoxyguanosine 5’-Monophosphate; 5-N-acetyl-α-D-Neuraminic acid; Alpha.-D-Galactose has a bad character |’α| for property http://www.w3.org/2004/02/skos/core#example"
WARN:Any changes or updates to a given substance will result in a new version. This could include changes in the definition of the substance or the addition of names or codes. The version of substances should be tracked. Submitters should also indicate if it is a new version of a previous submission. Where no “Version Number” and “Effective Date” have been assigned by an authority source, the version number shall be set as 0 with the date set as the date of initial submission of the substance. has a bad character |“”“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:“Subunit 1 position 10 — Subunit 2 position 16” refers to a disulfide linkage between the residue of cysteine in the position 10 and 16 respectively of the first and second subunit. A convenient shorthand such as 1_10-2_16 could also be used. has a bad character |“—”| for property http://www.w3.org/2004/02/skos/core#example
WARN:Disulfide linkages imply that two cysteines connect forming a sulfur to sulfur linkage. There are also instances where disulfide linkages can be formed through other modified or substituted acids or amino acids containing a thiol (see Table C.3 — Desmopressin Acetate (USAN); Desmopressin Acetate Hydrate (JAN)). has a bad character |—| for property http://www.w3.org/2004/02/skos/core#note
WARN:en – English, de – German, fr –French has a bad character |–––| for property http://www.w3.org/2004/02/skos/core#example"
WARN:If a unique `Substance ID` has been assigned, this `Substance ID` is specified based on the Substance Name controlled vocabulary. In the absence of a unique `Substance ID` , e. g. for the initial submission of the substance, this data element is not mandatory.
The ID will only be released to the public if the defining information is in the public domain or if a company that provides the defining information requests public release or releases the code in public marketing materials. An ID will always be issued to an organization that requests an ID and supplies the information necessary to define a substance. A flag to control the release of the ID to the general public is part of the Reference Source information . Defining information found in patents will usually not be sufficient to release the ID to the public. has a bad character |``````| for property http://www.w3.org/2004/02/skos/core#note"
WARN:For a Quantity of “71,9” and a Unit “% {w/w}” the Amount text could be: “Equivalence Factor: 0,72”Killing by cold shock at -20⁰ C, Microscopic inspection, and dried in a fluid bed dryer and controlled air temperature and moister. has a bad character |“”“”“”⁰| for property http://www.w3.org/2004/02/skos/core#example"
WARN:""June –August"", ""Shock frozen directly after harvesting"", ""Provinces Shandong, Jiangsu, Sichuan"" has a bad character |–| for property http://www.w3.org/2004/02/skos/core#example"
WARN:Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information has a bad character |——| for property http://purl.org/dc/terms/title
WARN:The preferred term of the related substance is captured; this information is required when there is a “Substance Relationship”; The substance name is implicit and derived from the Substance ID. has a bad character |“”| for property https://purl.iso.org/idmp/businessRules
WARN:If a unique “Substance ID” has been assigned, this “Substance ID” is specified based on the Substance Name. In the absence of a unique “Substance ID” e.g. for the initial submission of the substance this data element is not required. has a bad character |“”“”“”| for property http://www.w3.org/2004/02/skos/core#note"
WARN:For Herbals, this element shall be Mandatory. The accepted scientific name for plants is provided by Kew Gardens’ Medicinal Plant Names Services (MPNS). The names for other organisms will be provided by other authoritative sources. has a bad character |’| for property https://purl.iso.org/idmp/businessRules"
WARN:All medicinal products consist of substances; these substances can be active ingredients, excipients, or packaging materials. There are two fundamental levels of information described in ISO 11238, a “Substance level"" and a “Specified Substance level”. Both levels are included in the more generic concept of an ingredient. At the Substance level, substances are defined based on inherent attributes rather than use or method of manufacture. At the Specified Substance level, four separate groups of elements provide additional information.
In order to define or distinguish material either at a Substance or Specified Substance level, a number of attributes should be taken into consideration.
— For chemicals, the molecular structure is captured at the substance level.
— For proteins, the amino acid sequence, sites and type of glycosylation, and the presence and position of disulfide bonds are captured at the substance level.
— For nucleic acids, the sequence, type of sugar and linkage are captured at the Substance level.
— For other polymers, the monomers used to synthesize the polymer, the structural repeat units, the molecular weight and/or a property related to molecular weight (e.g. viscosity), the source of naturally derived polymers and any modifications that irreversibly alter the molecular structure are captured at the substance level.
— For structurally diverse material, taxonomic, anatomical and fractionation information, properties related to the underlying molecular structure of the material, and modifications that alter the underlying molecular structure are captured at the substance level.
— A Mixture consists of a simple combination of Single Substances that are either isolated together or are the result of the same synthetic process. This applies also to a homologous group of structurally diverse single substances used to prepare an allergen extract. The biological source of the mixture is also captured where relevant at the substance level. Proportions are not captured at the Substance level. It should be noted that a Mixture description should only include the substances that are generally or consistently present in the material. This excludes impurities and degradants.
Other attributes will be specific to the Specified Substance levels:
— Constituent substances in a multi-substance material;
— Proportions of constituent substances in a multi-substance material;
— Physical state;
— Grade or purity of material;
— Manufacturing information;
— Analytical data, Specifications and Tests.
There are four groups of elements that are used to further define and specify Substances. Specified Substances are always composed of at least one substance.
Specified Substance Group 1 is typically used to define:
— multi-substance materials consisting of multiple substances, which are not defined as mixture;
— defining information regarding homeopathic-, plasma derived-, vaccines substances, herbal and allergenic extracts;
— physical state, including polymorphic forms;
— detailed glycosylation information.
Specified Substance Group 2 is typically used to define:
— Manufacturer, manufacturing process and critical process version number as well as in some cases extended manufacturing information are used to provide information regarding herbal and allergenic extracts when multiple extraction methods with different solvent compositions are used or a stepwise manufacturing process is in place describing an extraction method followed by a general modification process of the extract e.g. modified allergen extract, modified vaccines by multiple modification processes.
Specified Substance Group 3 is typically used to define:
— Grade or level of purity (Pharmacopoeial Specifications) and In-house specification used to cover a set of specifications of all approved manufacturers for the substance.
Specified Substance Group 4 is typically used to define:
— Detailed specification information including analytical information to be used in tests;
— Detailed manufacturing information. has a bad character |““”————————————————————| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The value ‘Yes’ shall be specified to describe a mixture being an extract of a homologous group of substances. has a bad character |‘’| for property https://purl.iso.org/idmp/businessRules
WARN:In order to distinguish a mixture (a substance consisting of ‘closely related components’ as a result from the same synthetic process) from a mixture substance being an extract of a homologous group of substances as a result of the same synthetic process - which may have related (allergenic) components - the value ‘Yes’ shall be specified in the attribute ‘Is Multi-Substance Starting Material’. has a bad character |‘’‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition
WARN:The reference source type in which the data elements were actually found.
All reference sources shall be associated with a type. The type shall actually identify the source of the information if it is a public database or naming authority. For official names and defining information, the primary source should be used if available. A single source can be used for many data elements. Public databases particularly those of official naming bodies, regulatory submissions, manufacturer‘s technical specifications, scientific journal articles and pharmacopoeias are all sources that can be used. has a bad character |‘| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:All reference sources shall be associated with a type. The type shall actually identify the source of the information if it is a public database or naming authority. For official names and defining information the primary source should be used if available. A single source can be used for many data elements. Public databases particularly those of official naming bodies regulatory submissions manufacturer‘s technical specifications scientific journal articles and pharmacopoeias are all sources that can be used. has a bad character |‘| for property http://www.w3.org/2004/02/skos/core#definition
WARN:There are a wide variety of substances described as structurally diverse substances. A Structurally diverse substance is a type of polydisperse substance isolated from a single source that is a complex combination which cannot be described as a mixture of a limited number of single substances. This category would be used to describe the following class of substances.
— Herbals — The Herbal preparation OIL is discussed in B.7.2 of the Chemical Annex B. The Herbal preparations, Extract and exudates as well as the (Herbal) Substance (fresh) and Herbal Drug are discussed in the Herbal Annex E.
— Homeopathic Substances are discussed in Annex F.
— Plasma-derived substances used in Blood products are discussed in Annex G.
— Vaccines — are discussed in Annex I.
— Allergens — are discussed in Annex J.
— Polyclonal Immunoglobulins — to be addressed in the next edition of this document.
— Cells, tissues, complex animal derived products — to be addressed in the next edition of this document.
— Minerals —are discussed in the annexes where relevant.
For organism-based substances, the parent organism is essential defining information.
The majority of these substances will be derived from a biological organism, but they could be complex natural materials such as coal tar or mineral oil. has a bad character |——————————————| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The type ofisotopic substitution present in a single substance:
— specific if the site of attachment/substitution indicated in structure
— non-specific if the nuclide is distributed throughout molecule or substance
- unknown if site unknown.
Substitution refersto the relationship between the nuclide and the rest of the substance.
Applicable for single substances that contain a radionuclide or a non-natural isotopic ratio, e.g. 13C enriched material. All radionuclide and non-natural isotopes will also be represented in the structural representation. has a bad character |——| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The class ‘Specification Version’ is related to the class Specified Substance Group 4. This is done to minimize the maintenance of Specified Substance Group 4 identifiers. When a specification is updated, the version can be laid down in this element group with no effect on the Specified Substance Group 4-ID itself, since the manufacturing process and critical process version number are the same. The element group contains the attributes ‘Version’ and ‘Version Date.’ has a bad character |‘’‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:“Pharmaceutical dose form” can refer to the administrable dose form or the manufactured dose form, depending on the product that it is describing. has a bad character |“”| for property http://www.w3.org/2004/02/skos/core#note"
WARN:A specification[21] is defined in accordance with ICH Topic Q 6 A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (CPMP/ICH/367/96), 6 October 1999 as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance should conform to be considered acceptable for its intended use. ""Conformance to specifications"" means that the drug substance, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. Specifications are one part of a total control strategy for the drug substance designed to ensure manufactured substance quality and consistency. Specifications are chosen to confirm the quality of the drug substance rather than to establish full characterization, and should focus on those characteristics found to be useful in ensuring the safety and efficacy of the drug substance used in medicinal products.
In Figure 31 the class ‘Specification Version’ is related to the class Specified Substance Group 4. This is done to minimize the maintenance of Specified Substance Group 4 identifiers. When a specification is updated, the version can be laid down in this element group with no effect on the Specified Substance Group 4-ID itself, since the manufacturing process and critical process version number are the same. The element group contains the attributes ‘Version’ and ‘Version Date'.
""The element group ‘Specification’ is meant to lay down the boundary specifications for a Substance or Specified Substance Group 1. The Substance or Specified Substance Group 1 is tied to its manufacturer having a Specified Substance Group 2 ID or is related to a Pharmacopoeial Grade or ‘In house’ Grade having a Specified Substance Group 3 ID. has a bad character |‘’‘’‘‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The codedConcept associates a concept for a selected language and geographical region (e.g. in English for the UK) with zero to many translations of that same concept for different languages and/or geographical regions (e.g. in French for France, in German for Germany). The codeTermPair code for the concept for the user-selected language and region is used for the “value” element, and zero to many codeTermPair codes for that same concept for different languages and/or regions are used for the “translation” element; together these define the codedConcept data type. Data type that groups together a set of code term pairs that represent a single concept but differ in language and/or geographical region. has a bad character |“”“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:If a unique “Specified Substance ID” has been assigned, this “Specified Substance ID” is specified based on the Substance Name controlled vocabulary.
In the absence of a unique “Specified Substance ID” e. g. for the initial submission of the substance this data element is not required. has a bad character |“”“”“”| for property http://www.w3.org/2004/02/skos/core#note"
WARN:en – English, de – German, fr –French has a bad character |–––| for property http://www.w3.org/2004/02/skos/core#example"
WARN:The language used to provide the structured substance information shall be specified according to the XML standard’s xml:lang attribute specification, which is based on ISO 639-1, alpha-2 codes has a bad character |’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The stereochemistry of the substance should be indicated in the structure and is captured here. Special cases of stereochemistry that can’t be indicated in the structure shall be described based on a controlled vocabulary.Mixtures of stereoisomers shall be represented explicitly as a mixture of substances with absolute stereochemistry. In case the absolute stereochemistry is unknown the substance definition should be marked as Incomplete has a bad character |’| for property http://www.w3.org/2004/02/skos/core#definition
WARN:The stereochemistry of the substance should be indicated in the structure and is captured here. Special cases of stereochemistry that can’t be indicated in the structure shall be described based on a controlled vocabulary.Mixtures of stereoisomers shall be represented explicitly as a mixture of substances with absolute stereochemistry. In case the absolute stereochemistry is unknown the substance definition should be marked as “Incomplete”.
The overall stereochemistry of the substance should be indicated in this field. has a bad character |’“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:This element will indicate the orientation of the linkage. The 3‘-5‘ linkage is the most prevalent form.
The entity that links the sugar residues together should also be captured. For nearly all naturally occurring nucleic acid the linkage is a phosphate group. For many synthetic oligonucleotides phosphorothioate linkages are often seen. Linkage connectivity is assumed to be 3’→5’. If the linkage is either 3’→3’ or 5’→5’ this should be specified. has a bad character |‘‘’→’’→’’→’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:3’→5’, 3’→3’ or 5’→5’ this should be specified. has a bad character |’→’’→’’→’| for property https://purl.iso.org/idmp/allowedValues"
WARN:The country where the plant material is harvested or the countries where the plasma is sourced from as laid down in accordance with the Plasma Master File.
For “Plasma-derived substances” the attribute country of origin provides information about the countries used for the manufacturing of the Cryopoor plama or Cryoprecipitate. has a bad character |“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The amount subclause serves to provide the quantitative or qualitative values that are associated with a variety of elements. The same format will be used for all quantitative, semi-quantitative and qualitative values. Amounts may be a single value or a range (with low or high limits or both). An 'amount type' may be associated with an amount to state if the value needs to be interpreted as an average or an exact or approximate quantity. The attribute ‘Non-numeric Value’ is used to carry a value that is purely textual, with no numeric component. The ‘Amount Text’ is used for additional text to explain a numeric value. has a bad character |‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The nucleotide present at the 5’ terminal should be specified based on a controlled vocabulary.
Since the sequence is represented from the 5' to the 3' end, the 5’ prime nucleotide is the letter at the first position in the sequence. A separate representation would be redundant. has a bad character |’’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:Each property shall be provided with a fully terminologically defined concept for measurements. Such definition would include any necessary “types” such as this. has a bad character |“”| for property https://purl.iso.org/idmp/allowedValues
WARN:Information on assays used to determine identification, potency and impurities as well as the analytical method references are captured as attributes by the element group ‘Analytical Method’ e.g. ‘Analytical Method Type’, ‘Analytical Method’, Analytical Method Details’ and ‘Analytical Method Reference Data’. The 'Analytical Method' element group is proceeded by the element group ‘Analytical Method Version’ with the attributes ‘Version and ‘Version Date'. The attribute 'Analytical Method Type' may have the values ‘Chemical', ‘Biological’ or ‘Physical’. The attribute 'Analytical Method' may have the values e.g. HPLC–method, reverse phase HPLC, rp-LC-MS, Capillary Electrophoresis, Bioassay etc. Details of the Analytical Method can be described as text and the attribute 'Analytical Method Reference Data' refers to reference literature or reference may be made to an earlier version of the method. The analytical method details and reference data can be captured in a fielded format. The analytical method used has to comply to ICH Topic Q2(R1) ’Validation of Analytical Procedures: Text and Methodology’[20], see Figure 32. has a bad character |‘’‘’‘’’‘’‘’‘‘‘‘’‘’–’’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:Element group 'Potency': Attribute 'Potency Assay Type' is a controlled vocabulary with values: Assay/ strength, and Bioassay.
‘Strength’. Assay: A specific, stability-indicating procedure should be included to determine the content of the (new) drug substance. In many cases, it is possible to employ the same procedure (e.g., HPLC) for both assay of the new drug substance and quantitation of impurities
Potency Description: A description of the assay shall be provided. has a bad character |‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information has a bad character |——| for property http://purl.org/dc/terms/title
WARN:an optional indicator for use where veterinary-only terms are also provided in the same database, indicates that the concept is for either “human and veterinary” or “veterinary only” use (default value is “human and veterinary”) has a bad character |“”“”“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:In order to distinguish a mixture a substance consisting of ‘closely related components’ as a result from the same synthetic process from a mixture substance being an extract of a homologous group of substances as a result of the same synthetic process - which may have related allergenic components - the value ‘Yes’ shall be specified in the attribute ‘Is Multi-Substance Starting Material’. has a bad character |‘’‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition
WARN:The area of hybridization should be described if applicable for double stranded RNA or DNA. The number associated with the subunit followed by the number associated to the residue shall be specified in increasing order.
The underscore “_” shall be used as separator as follows: “Subunit_number Residue”. has a bad character |“”“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The stereochemistry of the substance should be indicated in the structure and is captured here. Special cases of stereochemistry that can’t be indicated in the structure shall be described based on a controlled vocabulary.Mixtures of stereoisomers shall be represented explicitly as a mixture of substances with absolute stereochemistry. In case the absolute stereochemistry is unknown the substance definition should be marked as “Incomplete”. has a bad character |’“”| for property http://www.w3.org/2004/02/skos/core#definition
WARN:Homeopathic substances are described using the Attribute Type ‘Particular Homeopathic’ and allergen substances the Attribute Type ‘Particular Allergen’. The Attribute Types ‘Particular Herbal’ or ‘Particular Herbal preparation’ shall be used to further describe characteristics of the Substance (fresh) and Substance (Herbal Drug). The Attribute Type ‘Cryopoor Plasma Process Flow’ is used to describe plasma-derived substances. The Attribute Type 'Particular Vaccine' is used to describe vaccines.
Physical attributes shall be used to describe Chemical, Protein, Nucleic acid and Polymer substances. has a bad character |‘’‘’‘’‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging has a bad character |——| for property http://purl.org/dc/terms/title"
WARN:The Equivalence Factor shall be ≤1,00. It is formed by dividing the molecular weight of the (parent) substance (active moiety)/molecular weight of the corresponding salt or salt hydrate or hydrate . has a bad character |≤| for property https://purl.iso.org/idmp/businessRules"
WARN:The value is IMPLICIT and can be derived by the “Substance Classification — Subtype “if available.
Jurisdictional requirements should further define the appropriate level within a code system that should be used. has a bad character |“—“| for property https://purl.iso.org/idmp/businessRules"
WARN:Element group: ‘Impurity’. The attribute 'Impurity type' should be provided e.g. Residual Solvent, Impurity from a starting material, Manufacturing process impurity, Degradant. Some impurities can be both an impurity obtained from the manufacturing process and a degradant.
Information shall be provided whether or not an impurity is Qualified.
Information shall be provided whether or not an impurity is a Degradant.
The Impurity Substance ID and Impurity Substance Name shall be provided. Impurities shall be registered as a substance in their own right. has a bad character |‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:Protected from light at –20 °C to –24 °C; Stored protected from light at 0 °C, until processed; Plants are harvested during the whole year after they have been cultivated for at least two growth periods; Undamaged tubers and stored under dry conditions; measured under 101 kPa; Physical state: Liquid, at 0 °C, 31.29 atm at equilibrium; 1 Volume part 20 °C and at a pressure of 101 kPa; Measured at 20 °C; Measured at pH range of 2,5 to 10,5 has a bad character |–°–°°°°°| for property http://www.w3.org/2004/02/skos/core#example"
WARN:ATC, NDF-RT (National Drug File – Reference Terminology), NCI, AHPA, MESH; Therapeutic Category of Drugs in Japan has a bad character |–| for property http://www.w3.org/2004/02/skos/core#example"
WARN:The name of the maternal species constituting the hybrid organism should be specified.
For plants, the parents aren’t always known, and it is unlikely that it will be known which is maternal and which is paternal. has a bad character |’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The stereochemistry of the substance should be indicated in the structure and is captured here. Special cases of stereochemistry that can’t be indicated in the structure shall be described based on a controlled vocabulary.Mixtures of stereoisomers shall be represented explicitly as a mixture of substances with absolute stereochemistry. In case the absolute stereochemistry is unknown the substance definition should be marked as “Incomplete”.
The overall stereochemistry of the substance should be indicated in this field. has a bad character |’“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:To be used to express the lower limit of a range of values, if applicable. Amounts may be a single value or a range with low or high limits or both. It should be noted that there can be two types of low limit one is a limit on actual values and the other is the lower limit of the average of values ‘Amount Type’ is used to distinguish . The low limit can be used alone to express one-sided ranges greater than or equal to this limit NLT. It can also be used to express NLT not less than values. has a bad character |‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The “Source Material Type” values are presented based on the “Source Material Class” values above. Because organic/inorganic is just a class best captured in terminology of the source material types, only one data element is needed for Type which implies Class.
For Herbals, this class shall be Mandatory. has a bad character |“”“”| for property https://purl.iso.org/idmp/businessRules"
WARN:Health Informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances has a bad character |——| for property http://purl.org/dc/terms/title
WARN:Structural modifications are used to describe in principle covalent modifications or essential associations of moieties with a protein, nucleic acid, or structurally diverse material. Covalent modification for a protein, nucleic acid or structurally diverse material typically means an amino acid substitution, a C-/N-terminal modification of a protein or base or 5’-, 3’- modifications of nucleic acids. The tight and/or stoichiometric association of moieties to macromolecular material by ionic forces, chelate formation, van der Waals interactions, or dipole moment interactions are also considered structural modifications since they may affect the tertiary structure of the protein/peptide or are an essential element of the drug substance (e.g. a chelated radionuclide). When peptide or nucleic acid chains are tightly associated either through covalent bonds or strong non-covalent interactions (e.g. Factor VIII: Von-Willebrand Factor interactions, Watson-Crick base pairing) they will be described as subunits of the respective protein or nucleic acid.
In case of N-Terminal modification and C-Terminal modification of a Protein subunit, the Modification class is mandatory.
has a bad character |’’| for property http://www.w3.org/2004/02/skos/core#example"
WARN:The Modification subclause is to be used to describe irreversible modifications to material (e.g. PEGylation, phosphorylation, hydrogenation) or reversible modifications that may affect tertiary structure. The modifications may be physical, chemical, enzymatic, etc. Modifications may be described by their structural result (substitution of moieties to residues, etc.) or by the process, reagents, or processing time if a specific structural modification cannot be determined (e.g. aggregated albumin).
A minimal description of the modification process shall be generated when a definitive structural modification cannot be determined.
This subclause applies to:
— Nucleic Acids;
— Proteins;
— Polymer;
— Structurally Diverse Substances;
— Mixture;
— Specified Substance Group 1.
Modifications will be divided into structural modifications where the existing molecular structure is discretely modified (either covalent modification, ionic modification including salt and solvate formation or modification by chelate formation), physical modifications where no new covalent bonds are formed and agent modifications where the chemical modifications are diverse or unclear.
has a bad character |——————| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The residues that contain a given sugar entity shall be captured. Each sugar present in the nucleic acid will be represented. The residues that contain a given sugar shall be captured. The order of given residues will be captured in the 5‘-3‘direction consistent with the base sequences listed above. has a bad character |‘‘| for property http://www.w3.org/2004/02/skos/core#definition
WARN:The residues that contain a given sugar shall be captured. The order of given residues will be captured in the 5‘-3‘direction consistent with the base sequences listed above. has a bad character |‘‘| for property http://www.w3.org/2004/02/skos/core#definition
WARN:The element group ‘Attribute Parameter’ is used to describe additional conditions for a certain Characteristic Attribute parameter e.g. the temperature measured at a pH value. has a bad character |‘’| for property http://www.w3.org/2004/02/skos/core#definition
WARN:There are three instances related to the information described above:
— component (part of a multi-substance material);
— constituent, single substance having a substance role (parent, marker, eluent etc);
— a particular case of Constituent Component used in a mixture having a relationship (part of a homologous group). has a bad character |———| for property http://www.w3.org/2004/02/skos/core#note"
WARN:Store at 25 °C, 60 % RH, protected from light, in double LDPE bags in a fibre drum has a bad character |°| for property http://www.w3.org/2004/02/skos/core#example"
WARN:Examples of the attributes captured by each Attribute Type are described below. The Attribute Names that are captured for each Attribute Type may be further expanded.
The Attribute Name for the Attribute Type ‘Particular Homeopathic’ is ‘Substance dilution potentization grade’.
The Attribute Names to be captured by the Attribute Type ‘Particular Herbal’ are: Wild/Cultivated; Degree of comminution; Process state; Growth state; Harvesting time; Harvesting method; Decontamination process; Country of origin, Geographical location, Storage time and Storage temperature.
The Attribute Name to be captured by the Attribute Type ‘Particular Herbal preparation’ is Drug Extract Ratio (DER), which describes the quantity of native Herbal Substance that is used to prepare 1 g Herbal extract. In this context, ‘Herbal Substance’ can be either a Substance (fresh) or a Herbal Drug.
The Attribute Names to be captured by the Attribute Type ‘Particular Allergen’ are: Degree of Comminution, Process state, Wild/ Cultivated, Growth state, Feeding composition, Harvesting/killing process, Harvesting Ttme, Decontamination process, Country of origin, Geographical location, Storage time and Storage condition.
The Attribute Names captured by the Attribute Type ‘Cryopoor Plasma Process Flow’ are: Country of origin; Pathogen test, testing strategy.
The Country of origin is directly coupled to the plasma pool and the manufacturer. It shall include the subset of countries in which the collection organizations are located from which plasma for manufacturing of a specific plasma-derived product(s) is obtained.
The Testing strategy is directly coupled to the plasma pool and the manufacturer. The manufacturer of a Cryoprecipitate sourced from a plasma pool is captured at the Specified Substance Group 2 information level.
The Attribute Names captured by the Attribute Type ‘Particular Vaccine’ are: History of the strain; Passage of the master seed; Passage of the working seed lot; ‘Cultured on Vero cell’ e.g. Polio vaccines or Cultured on MDCK (Madin Darby canine kidney) cells; Cultured on embryonated fertilized hens eggs.
The Attribute Names captured by the Attribute Type ‘Particular ATMP’ is HEK293 cells for the adeno associated viruses used for gene therapy.
The Attribute Names captured by the Attribute Type Physical are: melting point; boiling point; critical temperature; critical pressure; critical density; triple point; density; solubility; pKa; UV absorption maxima. has a bad character |‘’‘’‘’‘’‘’‘’‘’‘’‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:This subclause shall provide information on the version of the substance. Where no “Version Number” and “Effective Date” have been assigned by an authority source, the version number shall be set as 0 with the date set as the date of initial submission of the substance. Any changes or updates to a given substance will result in a new version. This could include changes in the definition of the substance or the addition of names or codes. The version of substances should be tracked. Submitters should also indicate if it is a new version of a previous submission. has a bad character |“”“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:Applicable only if ‘Source Material Type’ is human or mammalian. Not applicable for Herbals. has a bad character |‘’| for property https://purl.iso.org/idmp/businessRules
WARN:The unit of presentation is a concept that is used in describing the qualitative unit in which the strength or quantity of the manufactured item or pharmaceutical product are presented and described, in cases where a quantitative unit of measurement is not applicable. It is used where the strength may be described in terms of “each” in a general manner; in such a case, “each” would be replaced by “per tablet”, “per puff”, “per patch”, etc. It is also used where the strength or total quantity of a manufactured item or pharmaceutical product is described in terms of the packaging, such as “100 ml per bottle”. has a bad character |“”“”“”“”“”“”| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The name of the paternal species constituting the hybrid organism should be specified.
For plants, the parents aren’t always known, and it is unlikely that it will be known which is maternal and which is paternal. has a bad character |’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:“Structural Repeat Unit: <A><amount or number of SRU/per polymer ratio>”,
Example: Synthetic Polymer: Polyethylene Glycol 3350
Example Biological Polymers:
N. meningitidis group A polysaccharide:
“<A = →6)-DManpNAc(3/4OAc)-α-(1→OPO3)>"",
N. meningitidis group C polysaccharide:
""<A = →9)-DNeup5NAc(7/8OAc)-α-(2→>""
N. meningitidis group W135 polysaccharide:
“<A = →4)-DNeup5NAc(7/9OAc)-α-(2→6)-D-Gal-α-(1→>"",
N. meningitidis group Y polysaccharide:
""<A = →4)-DNeup5NAc(7/9OAc)-α-(2→6)-D-Glc-α-(1→""
EXAMPLE Defibrotide (Porcine). has a bad character |“”“→α→→α→“→α→α→→α→α→| for property http://www.w3.org/2004/02/skos/core#example"
WARN:A Substance Name shall always correspond to at least one and only one Substance Name Type.
The Preferred Name is the name that describes at least all moieties of a substance and shall be used in all EU languages, e.g. Benzathine Benzylpenicillin tetrahydrate (Dutch: Benzathinebenzylpenicillinetetrahydraat).
For the Substance (fresh) (e.g. Harpagophytum procumbens (Burch.) DC. ex Meisn., Root) the Substance Name Type shall be ""Other"".
Specified Substance Group 1, 2 and 3 name types are used to guide the user with regards to which level the substance name belongs to e.g. water for injection – Ph.Eur. is a name having the substance name type: Specified Substance Group 3. has a bad character |–| for property https://purl.iso.org/idmp/businessRules"
WARN:Each name shall be associated with one type.
Every substance name shall have one name type. When a Substance has the Substance Name Type e.g. Other Name, but also an official name exists, which will be used then the Substance Name element group should be repeated with the Name referring to the Official Name and the Substance Name Type should be ‘Official’, see Table B.1. Official names are typically nonproprietary names used in a given jurisdiction and domain to refer to a specific substance. The domain, jurisdiction, and authority that assigned the name (USAN, INN, JAN etc.) and the language of the name are also captured.
Systematic names will typically be used for simple chemicals and structurally diverse materials where the definitions are based on a chemical structure or systematic taxonomic information. For chemicals, these names are typically derived from IUPAC or CAS systems of nomenclature. From the systematic names of chemicals, a molecular structure can typically be derived and the name can be checked by a number of chemical drawing programmes that convert a given name to a molecular structure. Brand names are names by which a company identifies a given substance typically for marketing purposes. Other names associated with a given substance are for instance common names. Company codes (also known as lab/laboratory codes or clinical trial codes) are also treated as names. They are assigned by a given company to substances in clinical or preclinical development. has a bad character |‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:Under the specification category ‘Other’ values are grouped like Heavy Metals, Loss on Drying, Appearance, pH, Residual solvents and Water content etc.
‘Appearance’ describes a qualitative description of the substance (e.g., solid state form, size, shape, and colour). If any of these characteristics change during manufacture or storage, this change should be investigated and appropriate action taken. The acceptance criteria should include the final acceptable appearance.
The attribute Specification ‘Type’ has the values: Chemical test, Physical test, Bioassay, Assay, Relative UV absorption (UV 254 nm /UV280 nm), In process specification and Re-test specification etc.
The element groups ‘Identity’, ‘Potency’ and ‘Other’ shall capture information about the identity, potency and appearance of a substance since at least one identity test, potency test and description of the substance shall be provided in accordance with the ICH Topic Q 6 A, 3.2.1 New drug substances. has a bad character |‘’‘’‘’‘’‘’‘’| for property http://www.w3.org/2004/02/skos/core#definition"
WARN:The particle size (specification) is captured as a characteristic attribute in combination with the amount group as was earlier described at the Specified Substance Group 1 information level. So ‘particle size’ is not included in the value list of the attribute Category and thus, the class ‘Other’ is not applicable. has a bad character |‘’‘’| for property http://www.w3.org/2004/02/skos/core#note"
WARN:“Chemical synthesis from starting materials, purification steps and recrystallization to obtain crystalline form 1”.
“Nuclide production by bombardment of [18O] by accelerated protons in a Cyclotron: 18O(p,n)18F, followed by radiolabelling of a precursor substance by a chemical substitution on a radio synthesizer. The substance is not isolated during manufacturing”.
“See, Document enclosed at Regulatory submission”.
“Mother tinctures prepared according to Ph. Eur. Method 1.1.10 are prepared by maceration using 1 part of Herbal Drug and 10 parts of ethanol of the appropriate concentration. Generally used for Herbal Drugs (fresh or dried)”.
“The preparation of a herbal extract’.
“Cutting, fragmenting”.
“Inoculation, Cultivation (including feeding composition), Harvesting and storing the mite culture and extraction”.
“Continuous plasma fractionation from Human Plasma for Fractionation”
“Fractionation, absorption, virus inactivation and depth filtration” has a bad character |“”“”“”“”“’“”“”“”“”| for property http://www.w3.org/2004/02/skos/core#example"
WARN:If a unique `Substance ID` has been assigned, this `Substance ID` is specified based on the Substance Name controlled vocabulary. In the absence of a unique `Substance ID` , e. g. for the initial submission of the substance, this data element is not mandatory.
The ID will only be released to the public if the defining information is in the public domain or if a company that provides the defining information requests public release or releases the code in public marketing materials. An ID will always be issued to an organization that requests an ID and supplies the information necessary to define a substance. A flag to control the release of the ID to the general public is part of the Reference Source information . Defining information found in patents will usually not be sufficient to release the ID to the public. has a bad character |``````| for property http://www.w3.org/2004/02/skos/core#note"
WARN:There are basically three potential mixture types. Most mixtures will be “all of” mixtures meaning that all of the constituents are present in the mixture. The other two types of mixture are “one of” or “any of”. “Any of” mixtures will mean that at least one of the constituents shall be present but other constituents may or may not be present. has a bad character |“”“”“”“”| for property http://www.w3.org/2004/02/skos/core#definition
WARN:The identifier of the maternal species constituting the hybrid organism should be specified based on a controlled vocabulary.
For plants, the parents aren’t always known, and it is unlikely that it will be known which is maternal and which is paternal. has a bad character |’| for property http://www.w3.org/2004/02/skos/core#definition"
- Running test : ["min 1" cardinality restrictions should be avoided because of performance considerations.]
- Running test : [Every ontology must have a rdfs:label, sm:copyright, cmns-av:copyright, dct:license, dct:abstract property.]
WARN: Ontology https://purl.iso.org/idmp/core has to have appropriate metadata.
WARN: Ontology https://purl.iso.org/idmp/iso-11239 has to have appropriate metadata.
WARN: Ontology https://purl.iso.org/idmp/iso-11238 has to have appropriate metadata.
- Running test : [Subproperties domains should not cross]
- Running test : [If we refer to something, it should have a type]
- Running test : [Count of individuals]
info,count
INFO: count of individuals,3215
- Running test : [Local names of classes and properties shouldn't contain dots.]
- Running test : [Count of deprecated resources]
info,count
INFO: count of deprecated resources,3
- Running test : [If we refer to something, it should have a type]
ERROR:https://purl.iso.org/idmp/MandatoryInformation is referenced by conformance but has no type.
ERROR:https://spec.edmcouncil.org/idmp/ontology/ISO/ISO11240-IdentificationAndExchangeOfUnitsOfMeasurement/hasLanguageCode is referenced by onProperty but has no type.
- Running test : [Subproperties ranges should not cross]
- Running test : [Equivalent classes may indicate polysemy spread accross multiple classes]
- Running test : [Count of OWL data type properties]
info,count
INFO: count of OWL data type properties,49
- Running test : [Count of OWL object properties]
info,count
INFO: count of OWL object properties,118
- Running test : [If we refer to something, it should have a type]
- Running test : [Object properties should not play the role of the isA relationship.]
- Running test : [We should avoid punning object and datatype properties]
- Running test : [Every Class and Property defined in ontology must have a rdfs:label and skos:definition]
WARN: https://purl.iso.org/idmp/TargetOrganismType has to have label and definition.
WARN: https://purl.iso.org/idmp/SubstanceCodeValue has to have label and definition.
WARN: https://purl.iso.org/idmp/AmountType has to have label and definition.
WARN: https://purl.iso.org/idmp/MoietyIdentifier has to have label and definition.
WARN: https://purl.iso.org/idmp/MaterialType has to have label and definition.
WARN: https://purl.iso.org/idmp/OtherMethodType has to have label and definition.
WARN: https://purl.iso.org/idmp/TargetName has to have label and definition.
WARN: https://purl.iso.org/idmp/StructuralRepeatUnit has to have label and definition.
WARN: https://purl.iso.org/idmp/HybridSpeciesPaternalOrganismIdentifier has to have label and definition.
WARN: https://purl.iso.org/idmp/NTerminalModification has to have label and definition.
WARN: https://purl.iso.org/idmp/VersionDate has to have label and definition.
WARN: https://purl.iso.org/idmp/CriticalProcessVersionNumber has to have label and definition.
WARN: https://purl.iso.org/idmp/CriticalParameter has to have label and definition.
WARN: https://purl.iso.org/idmp/ManufacturerRole has to have label and definition.
WARN: https://purl.iso.org/idmp/Translation has to have label and definition.
WARN: https://purl.iso.org/idmp/IssuerOfIdentifier has to have label and definition.
WARN: https://purl.iso.org/idmp/StructuralRepeat has to have label and definition.
WARN: https://purl.iso.org/idmp/ReferenceSourceURL has to have label and definition.
WARN: https://purl.iso.org/idmp/ReferenceInformationComment has to have label and definition.
WARN: https://purl.iso.org/idmp/ResidueModified has to have label and definition.
WARN: https://purl.iso.org/idmp/ManufacturerName has to have label and definition.
WARN: https://purl.iso.org/idmp/SpecifiedSubstance has to have label and definition.
WARN: https://purl.iso.org/idmp/StructuralRepeatUnitAmountType has to have label and definition.
WARN: https://purl.iso.org/idmp/SubstanceType has to have label and definition.
WARN: https://purl.iso.org/idmp/Comment has to have label and definition.
WARN: https://purl.iso.org/idmp/DevelopmentStage has to have label and definition.
WARN: https://purl.iso.org/idmp/PropertyParameters has to have label and definition.
WARN: https://purl.iso.org/idmp/ThreePrimeIdentifier has to have label and definition.
WARN: https://purl.iso.org/idmp/SpecifiedSubstanceGroup2 has to have label and definition.
WARN: https://purl.iso.org/idmp/PhysicalFormType has to have label and definition.
WARN: https://purl.iso.org/idmp/ManufacturingMaterialSubstanceName has to have label and definition.
WARN: https://purl.iso.org/idmp/AdministrationMethodClass has to have label and definition.
WARN: https://purl.iso.org/idmp/SubstanceNameJurisdiction has to have label and definition.
WARN: https://purl.iso.org/idmp/CodeTermPair has to have label and definition.
WARN: https://purl.iso.org/idmp/ManufacturingType has to have label and definition.
WARN: https://purl.iso.org/idmp/ProductionStep has to have label and definition.
WARN: https://purl.iso.org/idmp/OfficialNameType has to have label and definition.
WARN: https://purl.iso.org/idmp/Identity has to have label and definition.
WARN: https://purl.iso.org/idmp/OfficialName has to have label and definition.
WARN: https://purl.iso.org/idmp/OrientationOfPolymerization has to have label and definition.
WARN: https://purl.iso.org/idmp/FivePrimeIdentifier has to have label and definition.
WARN: https://purl.iso.org/idmp/SpecifiedSubstanceGroup2Identifier has to have label and definition.
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WARN: https://purl.iso.org/idmp/MixtureType has to have label and definition.
WARN: https://purl.iso.org/idmp/HybridSpeciesMaternalOrganismIdentifier has to have label and definition.
WARN: https://purl.iso.org/idmp/CharacteristicAttribute has to have label and definition.
WARN: https://purl.iso.org/idmp/SubstanceRelationshipValue has to have label and definition.
WARN: https://purl.iso.org/idmp/MultiSubstancePropertyParameters has to have label and definition.
WARN: https://purl.iso.org/idmp/hasUMLAttribute has to have label and definition.
WARN: https://purl.iso.org/idmp/conformance has to have label and definition.
WARN: https://purl.iso.org/idmp/businessRules has to have label and definition.
WARN: https://purl.iso.org/idmp/isUMLAttributeOf has to have label and definition.
WARN: https://purl.iso.org/idmp/allowedValues has to have label and definition.
WARN: https://purl.iso.org/idmp/currentConcept has to have label and definition.
- Running test : [We should avoid punning object and datatype properties]
- Running test : [Property subPropertyOf hierarchy shouldn't be circular.]
- Running test : [We should not make explicit references to owl:Thing]
- Running test : [Class subClassOf hierarchy shouldn't be circular.]
- Running test : [Deprecated resources should not be used.]
warning,resource
WARN: Deprecated resource https://www.omg.org/spec/LCC/Countries/ISO3166-1-CountryCodes/Macedonia is still in use.,https://www.omg.org/spec/LCC/Countries/ISO3166-1-CountryCodes/Macedonia
- Running test : [We should avoid punning object and datatype properties]
- Running test : [rdfs:comment shouldn't be used for ontology annotation.]
WARN: https://purl.iso.org/idmp/businessRules has an rdfs:comment annotation: Capture defined business rules according to the ISO standard.
WARN: https://purl.iso.org/idmp/allowedValues has an rdfs:comment annotation: Capture defined allowed values according to the ISO standard. This is preliminary and likely to be replaced by a different pattern with controlled lists.
WARN: https://purl.iso.org/idmp/hasUMLAttribute has an rdfs:comment annotation: This property is used to link UML objects with corresponding 'attributes' according to the ISO specification. Its use is preliminary and is assumed to change to a different modelling pattern.
WARN: https://purl.iso.org/idmp/isUMLAttributeOf has an rdfs:comment annotation: This property is used to link 'attributes' with corresponding UML objects according to the ISO specification. Its use is preliminary and is assumed to change to a different modelling pattern.
WARN: https://purl.iso.org/idmp/iso-11239 has an rdfs:comment annotation: This ontology contains entities of the domain of IDMP Dose Forms based on ISO standard ISO_11239_2012(en) Dose Forms
WARN: https://purl.iso.org/idmp/core has an rdfs:comment annotation: This artifact represents the core vocabulary of IDMP based on ISO standards:
ISO_11238_2018(en) Substance,
ISO_11239_2012(en) Dose form, unit, route of administration,
ISO_11240_2012(en) Unit details,
ISO_11615_2017(en) Medicinal product,
ISO_11616_2017(en) Pharmaceutical product,
ISO/TS 19844 E Implementation guideline for 11238,
ISO/TS 20443 E Implementation guideline for 11615,
ISO/TS 20451 E Implementation guideline for 11616,
Representation of information in agreement of IDMP requires application of further ISO standards:
ISO 639-1 Codes for names of languages (part 1: Alpha-2 code),
ISO 3166-1:2013 Codes for names of countries (part 1: Country codes),
ISO 8601 Data elements and interchange formats"
WARN: https://purl.iso.org/idmp/iso-11238 has an rdfs:comment annotation: Open Source - exact license to be clarified
WARN: https://purl.iso.org/idmp/conformance has an rdfs:comment annotation: Capture defined conformance information according to the ISO standard.
WARN: https://purl.iso.org/idmp/core has an rdfs:comment annotation: This ontology contains entities that are shared between different modules of IDMP ontology. The core ontology imports codelists that are shared between modules of the IDMP ontology.
- Running test : [We should avoid punning object and datatype properties]
- Running test : [No ontology may import itself.]