Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## Artifact List

Page standards status: Informative

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

### Structures: Abstract Profiles

These are profiles on resources or data types that describe patterns used by other profiles, but cannot be instantiated directly. I.e. instances can conform to profiles based on these abstract profiles, but do not declare conformance to the abstract profiles themselves.

Analysis Graphic | Any attached file that contains a graphical representation
Analytical Instrument Data | Any attached file that contains analytical instrument data
Attached Document (PDF) | An attached PDF file
Document Reference Attachment | A profile that represents the document or diagram in base64.
Graphic Reference | A Document Reference to any attachment that contains a graphical representation
Literal Coded Reference | An abstract profile to ensure the reference portion of a codeable reference is used, and that the reference is a literal reference to some resource in a bundle
Literal Reference | An abstract profile to ensure the reference is always a literal reference. Used in conjunction with a rule set to ensure every reference is also bundled.
PQCMC Attachment | Any attached file in a submission is required to have a type, data, and a title
Structure Data | Any attached file that contains structure data (e.g. SDFiles, MolFiles, INCHI)
Structure Data Reference | A Document Reference to any attachment that contains structure data
Text Only Codeable Concept | An abstract profile for the common scenario where only the text field is used and is required. Doesn't stop the coding portion from being used but it will not be parsed

### Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Basic Organization | A profile for the data elements required to identify the sponsor and/or the supplier of the drug products or substances.
Batch Formula Drug Product Identification | The Drug Product produced by the batch formula.
CMC eCTD 32P10 Document | Definition for a document bundle with the CMC eCTD 32P1 profiles (Description and Composition of the Drug Product).
CMC eCTD 32P32 Document | Definition for a document bundle with the CMC eCTD 32P32 profiles (Product Batch Formula).
CMC eCTD 32P55 Document | Definition for a document bundle with the CMC eCTD 32P55 profile (Product Characterisation of Impurities).
CMC eCTD 32S10 Document | Definition for a document bundle with the CMC eCTD 32S1 profiles (General Information).
CMC eCTD 32S23 Document | Definition for a document bundle with the CMC eCTD 32S23 profiles (Substance Control of Materials).
CMC eCTD 32S3 Document | Definition for a document bundle with the CMC eCTD 32S3 profiles (Substance Characterisation).
CMC eCTD SP4151 Document | Definition for a document bundle with the CMC eCTD SP4151 profiles (Specification).
Component Substance | 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.
ContainerClosure | Container Closure for drug product referred to in Drug Product Description.
Drug Product Batch Formula | 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.
Drug Product Batch Formula Ingredient | The amount details about the drug product ingredients in the batch. Use for Batch Formula.
Drug Product Component | The amount details about the drug product components to define the product composition in a product unit. Use composition.
Drug Product Description | Includes the properties of the drug product and components. Profile of Drug Product profile.
Drug Product Handle | Includes the essential identifying information of the drug product required to link to other profiles about the product in the eCTD structure. Profile on MedicinalProductDefinition.
Drug Product Impurities | List of drug product impurities. Profile of Drug Product profile.
Drug Substance | Drug Substance (Active Ingredient) nomenclature and characterization.
Drug Substance Handle | Includes the essential identifying information of the drug substance required to link to other profiles about the substance in the eCTD structure. Profile on SubstanceDefinition.
Drug Substance Impurity | Any component of the drug substance that is not the chemical entity for product composition.
Excipient Drug Substance | Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.
Manufactured Drug Product | 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.
Polymorphic Form | Alternate structure present in the drug substance
Quality Specification | A quality specification is for a drug product or drug substance (excipient, API or raw material).
Substance General Information | Substance General Information containing Drug Substance (Active Ingredient) nomenclature (3.2.S.1.1) and Substance Structure (3.2.S.1.2) profile.
eCTD Batch Formula | The fields needed to represent the Product Batch Formula to be included under the eCTD. References Sponsor Organization and Batch Formula
eCTD Product Characterisation of Impurities | The fields needed to represent the Product Characterisation of Impurities in a EctdComposition32P55 to be included under the eCTD. References Sponsor Organization and Product Characterisation of Impurities
eCTD Product Description and Composition | 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.
eCTD Specification | The fields needed to represent Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials.
eCTD Substance Characterisation | 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
eCTD Substance Control of 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.
eCTD Substance General Information | 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.

### Structures: Data Type Profiles

These define constraints on FHIR data types for systems conforming to this implementation guide.

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

### Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

Additional Information | 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.
Amount Ratio | The fields needed to represent an amount as a ratio.
Hierarchical Level |
Numeric level in the hierarchical value-set. As an example, this extension is used to distinguish between Test Category | Test Subcategory in Quality Specifications. Test Category is level 1 and Test Subcategory is level two. A constraint enforces values greater than zero.
Overage Extension | Extension for measurements related to excess for ingredients in the batch formula.
Product Batch Strength Textual Extension | Extension for strength as a string for ingredients in the batch formula.
Specification Status | A classification of the regulatory status of the specification.
Strength Type | Strength Type (for API)
Target Range | 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

### Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Analytical Instrument Data File Types | The acceptable file types that can be used in Analytical Instrument Data Files
Batch utilization Terminology | Terminology used to qualify the information pertaining to batch utilization in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Capsule Shell Classification Terminology | 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.
Chemical Structure Data File Type Terminology | 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.
Closure Type Terminology | Terminology used to qualify the information pertaining to closure types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Coating Purpose Terminology | 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.
Container Type Terminology | Terminology used to qualify the information pertaining to container types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Drug Product Component Function Category Terminology | 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.
Drug Route Of Administration Terminology | Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents.
Excipient Function Terminology | Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
GENC and ISO 3166 Intersection | The 3 letter country codes used in GENC and ISO have significant overlap: only the country codes in ISO 3166 that have an equivalent code in GENC may be used
Graphical File Types | The acceptable file types that can be used in graphical files
Impurity Classification Terminology | Terminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Ingredient Location Terminology | 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.
Manufactured Dose Form Terminology | Terminology used to qualify the information pertaining to the manufactured dose form.
Non-Percentage Units | Units of Measure terminologies that do not represent percentages
PQCMC Name Part Terminology | Terminology used to qualify the information pertaining to Name Part data in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Percentage Units | Units of Measure terminologies that represent the concept of a percentage
Pharmaceutical Dosage Form Terminology | Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the SPL documents.
Product Name Types Terminology | The type of the product name. Often the proprietary name is unknown at the time of submission.
Product Part Type Terminology | 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.
Quality Benchmark Terminology | Terminology used to qualify the information pertaining to quality benchmarks in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Release Mechanism Terminology | 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.
Release Profile Terminology | 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.
Representation Types | The different types of representations (graphical, structure/file and structure/text)
Source Type Terminology | Terminology used to qualify the information pertaining to source types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Specification Section Type Terminology | Local value set of all codes in Specification Type codes
Specification Status Terminology | Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Specification Type Terminology | Terminology used to qualify the information pertaining to specification types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Strength Type Terminology | Terminology used to qualify the information pertaining to strength types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Structure Data Types | The acceptable file types that can be used in Structure Data Files (MOL,SDF,INCHI,etc)
Substance Classification | Substance classes
Substance Name Type | A category of terminology used to qualify the information pertaining to the type of substance name in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Test Category Terminology | Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Test Method Origin Terminology | Terminology used to qualify the information pertaining to test method origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Test Usage Terminology | Terminology used to qualify the information pertaining to test usage in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
Units Of Measure | 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
eCTD sections Terminology | Value set of all codes in Code system PQCMC Comp Section Types.

### Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

PQ-CMC-FDA NCIt Hierarchy Supplement | Provides hierarchical relationships for value sets as a CodeSystem supplement to the NCI Thesaurus (NCIt)

### Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

3.2.P.1.0 Bundle | Description and Composition of the Drug Product bundle
3.2.P.3.2 Bundle for liquid | Batch Formula bundle for a liquid drug product
3.2.P.3.2 Bundle for two-layer tablet | Batch Formula bundle for a tablet drug product with two layers
3.2.P.4 Bundle | Specification bundle for an Excipient substance
3.2.P.5.1 Bundle | Specification bundle for a Drug Product
3.2.P.5.5 Bundle | Product Characterisation of Impurities bundle
3.2.P.5.5 Bundle 2 | Product Characterisation of Impurities bundle - example 2
3.2.S.1 Bundle | General Information bundle
3.2.S.2.3 Bundle | Control of Materials bundle
3.2.S.3 Bundle | Substance Characterisation bundle
3.2.S.4.1 Bundle | Specification bundle for an API substance
SDF File in a Structure Reference | A sample SDF file that can be referenced from the bundle profiles