A profile for the data elements required to identify an organization that manufactures, processes or tests drug products or substances.

A profile for the data elements required to identify the sponsor of the drug products or substances.

A profile for the data elements required to identify an organization that supplies drug products or substances.

Definition for a document bundle with the CMC eCTD 32P10 profiles.

Definition for a document bundle with the CMC eCTD 32S1 profiles.

Definition for a document bundle with the CMC eCTD 32S23 profiles.

Definition for a document bundle with the CMC eCTD SP4151 profiles.

Any raw material intended for use in the manufacture of a drug substance, or any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product.

A profile that represents the document or diagram in base64.

The amount details about the drug product components to define the product composition in a product unit. Use composition.

Description and coding of the container closure system. Profile of Drug Product profile.

Includes the properties of the drug product and components. Profile of Drug Product profile.

Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.

The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.

Alternate structure present in the drug substance

A quality specification is for a drug product or drug substance (excipient, API or raw material).

Includes the identifying information of the drug product. Profile of Drug Product profile.

Provides sufficient information to identify a drug substance. Profile on Drug Substance profile.

Substance General Information containting Drug Substance (Active Ingredient) nomenclature (2.3.S.1.1) and Substance Structure (2.3.S.1.2) profile.

The fields needed to represent the Product Description, Container Closure and Composition of the Drug Product to be included under the 3.2.P.1.0 heading of the eCTD. References Sponsor Organization, Drug Product Description, and Product Container Closure System.

The fields needed to Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials.

The fields needed to represent the Substance Control of Materials to be included under the eCTD 3.2.S.2.3 heading. References Sponsor Organization and Drug Substance Materials.

The fields needed to represent the Substance Nomenclature and Structure to be included under the 3.2.S.1 heading of the eCTD. References Sponsor Organization.

pq-specific Constraints on the Address datatype dealing with US addresses.

Any additional information

The packaging information including a brief description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance or drug product during their use in the clinical trials.

constituent content percent

Numeric level in the hierarchical value-set

A code that describes how to relate the given value to an acceptance value.

The constituent optional denominator is used then the unit is other than 1 per product part.

The IG version number of the bundle profile to which the instance conforms. Additionally, all the profiles of the resources in the bundle must conform to this version.

A classification of specification related to the kind of the entity it is referencing.

Values required in Ingredient.substance.strength

The sequential number assigned to each Test or Stage to specify the order of display on the Quality Specification.

Terminology used to qualify the information pertaining to chemical structure data file types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to closure types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to the coating purpose in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Product Characteristic for the characteristic element in ManufacturedItemDefinition for product composition.

Terminology used to qualify the information pertaining to conformance to criteria in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to container types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to drug product component function categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents.

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substance classes

Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

The GENC Standard specifies an information model for representing names and codes of geopolitical entities and administrative subdivisions, with supporting information. A geopolitical entity is a region controlled by a political community having an organized government and possessing internal and external sovereignty, most often as a State but sometimes having a dependent relationship on another political authority, or a special sovereignty status. Geopolitical entities may be divided into administratively subordinate divisions. A GENC code (or, synonymously, an ISO 3166 code element) for a geopolitical entity or administrative subdivision is a unique designation of that concept within a set of similar concepts established by a suitable authority. This information model is based on that of ISO 3166 but extended to capture additional information required by U.S. Government stakeholders.

Terminology used to qualify the information pertaining to numeric interpretation codes, Weight Operator codes and Amount Operator code in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to the manufactured dose form.

Terminology used to qualify the information pertaining to Name Part data in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to the classification of a capsule in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the SPL documents.

Local value set of all codes in the Code system.

A category of terminology used to qualify the information pertaining to the location of an ingredient within a product in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to the product part type in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to quality benchmarks in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Local value set of all codes in Relationship Types codes

A category of terminology used to qualify the information pertaining to release mechanism in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to release profile in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to source types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to specification types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to strength operators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to strength types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Waiting for NCIt codes are added for Product Ingredient Name Type

Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to test method origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to test usage in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to the sponsor or testing site unique identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to units of measure in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. Note: Includes SPL Unit of Presentation Terminology

Value set of all codes in Code system PQCMC Comp Section Types for bindings that require a value set instead of the code system.

Classification of a section of a PQ/CMC composition/document generally based on eCTD Module 3 section numbering for product and substance. A composition can have many section codes.

This is a dummy codesystem representing EMA. It contains all the codes that are usable within the IG. It exists because the publisher previously allowed using value sets from codesystems that it could not find (e.g. https://www.ema.europa.eu). This is no longer the case, so a temp code system must be defined in the IG.

This is a dummy codesystem representing NCIt. It contains all the codes that are usable within the IG. It exists solely because NCIt currently cannot be validated against and because https://example.com/ codesystems are not allowed by the validator.

The GENC Standard specifies an information model for representing names and codes of geopolitical entities and administrative subdivisions, with supporting information. A geopolitical entity is a region controlled by a political community having an organized government and possessing internal and external sovereignty, most often as a State but sometimes having a dependent relationship on another political authority, or a special sovereignty status. Geopolitical entities may be divided into administratively subordinate divisions. A GENC code (or, synonymously, an ISO 3166 code element) for a geopolitical entity or administrative subdivision is a unique designation of that concept within a set of similar concepts established by a suitable authority. This information model is based on that of ISO 3166 but extended to capture additional information required by U.S. Government stakeholders.

Waiting for NCIt codes to be added; then this may be deleted.

IG only code system of all codes in Code system.

Local value set of all codes in the Relationship Types code system.

Maps between ISO 3166-1-3 and GENC. In 6.0.0, SubstanceDefinition.sourceMaterial.countryOfOrigin is bound to <https://build.fhir.org/valueset-country.html> which is all of ISO 3166 including both 2 and 3 letter codes but should only be GENC.

An example of section 3.2.P.1.2 for a multilayer product

An example of section 3.2.P.1.1

An example of section 3.2.P.1.3 for a multilayer product

A quality specification is for a Drug Product

A quality specification is for an API

An attached SDfile. The ASCII file content is attached in base64.

Base 64 Document - png file

Monosodium D-thyroxine hydrate.png

Bundle containng nomenclature and molecular structure

A bundle for 3.2.P.1.0

Example raw material (Carrageenan) specification for CTD 3.2.S.2.3. Raw matrials and Excipients share the same profile but are in different bundles.

Example raw material (Citric acid) specification for CTD 3.2.S.2.3

An excipient in the two layer tablet

An API used in two layer table example.

API used in two layer table example

Example of Manufacturing site using the MfgTestSiteOrganization profile - Vandechemie

LEVOTHYROXINE SODIUM ANHYDROUS

Strength is captured for all excipients

Manufacture of Chemicals

eCTD Product Description and Composition for the two layer tablet example

This composition contains one section with reference to each raw material specification for the drug substance.

Provides sufficient information to identify a drug substance

Identification of the Drug Substance of the raw materials whose specifications are

Identification of the subject of the specification which is a sourced plant based raw materials. It contains the sourceMaterial backbone elements.

Identification of the subject of the specification. It is commonly used in the pharmaceutical industry as a stabilizer and preservative.

Identification of the subject of the specification

A profile for the data elements required to identify an organization that manufactures, processes or tests drug products or substances.

This example if for a Supplier Organization

FHIR document bundle with the CMC eCTD SP4151 profile for a Drug Substance

FHIR document bundle with the CMC eCTD SP4151 profile for a Drug Product

ComponentSubstance example showing the use use of the sourceMaterial backbone element

Manufacturing site instance of an Organization Example. There will be a type code in future

Polymorphic Form - DextroThyroxine

SponsorOrganization - Large Life

A company sponsor of a drug application

Example of a Sponsor type of Organization

one of the active ingredients in the two layer table example - aspirin

Example of a DrugProductComponent for an Inactive Ingredient

An active ingredient in the two layer table example - acetaminophen

Manufacturing site (Vidinaid) instance with second address line

Example raw material (water) specification for CTD 3.2.S.2.3

Includes the identifier of the drug product

Composistion containing eCTD Substance General Information

This is an example of the Substance Control of Materials bundle profile. It is to submit Module 3 of CTD 3.2.S.2.3 folder content to the FDA.

Composition SP4151 implementing eCTD 3.2.S.4.1.

Composition SP4151 implementing eCTD 3.2.P.5.1.