Any attached file that contains a graphical representation

Any attached file that contains analytical instrument data

A Document Reference to any attachment tha contains a graphical representation

Any attached file in a submission is required to have a type, data, and a title

Any attached file that contains structure data (e.g. SDFiles, MolFiles, INCHI)

A Document Reference to any attachment that contains structure data

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

The Drug Product produced by the batch formula.

Definition for a document bundle with the CMC eCTD 32P1 profiles.

Definition for a document bundle with the CMC eCTD 32P32 profiles (Product Batch Formula).

Definition for a document bundle with the CMC eCTD 32P55 profile (Product Characterisation of Impurities).

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 32S3 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.

Container Closure for drug product referred to in Drug Product Description.

A profile that represents the document or diagram in base64.

Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards.

The amount details about the drug product ingredients in the batch. Use for Batch Formula.

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

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

Includes the essential identifying information of the drug product required to link to other profiles about the product in the eCTD structure.

List of drug product impurities. Profile of Drug Product profile.

Drug Substance (Active Ingredient) nomenclature and characterisation.

Provides sufficient information to identify a drug substance. Profile on SubstanceDefinition.

Any component of the drug substance that is not the chemical entity for procduct composition.

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).

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 Batch Formula to be included under the eCTD. References Sponsor Organization and Batch Formula

The fields needed to represent the Product Characterisation of Impurities in a to be included under the eCTD. References Sponsor Organization and Product Characterisation of Impurities

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 heading of the eCTD. References Sponsor Organization, Drug Product Description, and Product Container Closure System.

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

The fields needed to represent the Substance Structure and Impurities to be included under the 3.2.S.3 heading of the eCTD. References Sponsor Organization, Drug Substance Structure, and Drug Substance Impurities

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 that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG.

represent an amount as a ratio in ManufacturedItemDefinition

Extension for measurement properties for ingredients in the batch formla.

A classification of the regulatory status of the specification.

Strength Type (for API)

The FHIR Range datatype uses Simple Quantities to represent the high and low bounds, which do not allow a comparator to be set. This extension allows the high and low bounds to have a comparator

The acceptable file types that can be used in Analytical Instrument Data Files

Terminology used to qualify the information pertaining to batch utilization 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 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.

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.

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

The acceptable file types that can be used in graphical files

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

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.

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

Units of Measure terminologies that do not represent percentages

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 Name Part data in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

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

Units of Measure terminologies that represent the concept of a percentage

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 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.

Local value set of all codes in Specification Type codes

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 types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

The acceptable file types that can be used in Structure Data Files (MOL,SDF,INCHI,etc)

Substance classes

A category of terminology used to quality the information pertaining to the type of substance name in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

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 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. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems).

Codes are temporarily defined as part of the PQ-CMC-FDA implementation guide. Some, but not all, are defined in NCIt. When all codes are in NCIt, they will migrate to the HL7 Terminology (THO). Note: Codes that exist in NCIt at time of ballot begin with 'C'.

Indicates patent or trademark status. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems)

Local value set of all codes in the Relationship Types code system.Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems)

The Excipient Raw representing Cochineal

Impurity substance for DIOXANE

Impurity substance - DICHLOROMETHANE

Drug Product with Impurities for AmphetamineSalt_1

FHIR document bundle with the CMC eCTD SP4151 profile for an Excipient

Impurity Substance - methylamine

Impurity Substance - elementalIron

Sponsor example for eCTD SP4151

FHIR document bundle with the CMC eCTD 32P55 profile for a Drug 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

Identification for the drug subtance used in a batch formula

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

Base 64 Document - png file

Monosodium D-thyroxine hydrate.png

Basic idenfier informion in MDI for the Drug Product with reference to the Batch Formula

Basic idenfier informion the Drug Product with reference to the Batch Formula for 2 layer example

Batch Formula Exmample for drug product with two component layers

Batch Formula Exmample for a liquid drug product

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

Composition SP4151 implementing eCTD 3.2.P.4.0

Quality Specification for Cochineal

A company sponsor of a drug application

Example of a Sponsor type of Organization

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 CodedOrganization 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

Example 2-layer inactive ingredient in batch formula

Example 2-layer inactive ingredient in batch formula. Contains the identiy and codes of the substance

Batch formula drug product example Active - Asprin

Batch formula drug product example Active

FHIR bundle with a CMC eCTD 32P32 profile

FHIR bundle with a CMC eCTD 32P32 profile

Composition 32P32 - Batch Formula Composition

Composition 32P32 - Batch Formula Composition with multiple parts

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

Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug.

Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults.

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

Idenfiers for the subtance used in a batch formula

Provides sufficient information to identify a drug substance

Identification of the Drug Substance of the raw materials whose specifications are for Aspirin.

Example Active ingredient in batch formula

Example inactive ingredient in batch formula

Example inactive ingredient in a batch formula in single part

Example inactive ingredient in a batch formula distributed over two parts

Example inactive ingredient in batch formula

Example inactive ingredient in batch formula

Example inactive ingredient in batch formula

Example inactive ingredient in batch formula

Example inactive ingredient in batch formula. Contains the identiy and codes of the substance

Example inactive ingredient in batch formula. Contains the identiy and codes of the substance

Example inactive ingredient in batch formula. Contains the identiy and codes of the substance

Example inactive ingredient in batch formula. Contains the identiy and codes of the substance

Example inactive ingredient in batch formula. Contains the identiy and codes of the substance

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 Product

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

ComponentSubstance example showing the use use of the sourceMaterial backbone element

Grape skin extract excipient

Maize starch excipient in the two layer tablet

An API used in seond layer of table example.

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

Polymorphic Form - DextroThyroxine

CodedOrganization - Large Life

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

Drug Substance Characterization for EthylAcetate

Manufacturing site (Vidinaid) instance with second address line

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

An Example FHIR Bundle containing data for the CMC eCTD 32P55 document

Impurity Substance - Phenylacetone

Example of Drug Product with Impurities

Includes the identifier of the drug product

Composition 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.

FHIR Composition for 32P55

FHIR composition for CMC eCTD SP4151

Composition SP4151 implementing eCTD 3.2.P.5.1.

Sponsor for Amphetamine Salts 32P55

Impurity substance - hydroxyApatite