Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Table of Contents

.. 0 Table of Contents
... 1 Home
... 2 General Instructions
... 3 Description and Composition of the Drug Product (3.2.P.1)
... 4 General Information (3.2.S.1)
... 5 Substance Control of Materials (3.2.S.2.3)
... 6 Specification (3.2.S.4.1, 3.2.P.4 and 3.2.P.5.1)
... 7 Artifact List
.... 7.1 Manufacturing and/or Test Site Organization
.... 7.2 Sponsor Organization
.... 7.3 Supplier Organization
.... 7.4 CMC eCTD 32P10 Document
.... 7.5 CMC eCTD 32S10 Document
.... 7.6 CMC eCTD 32S23 Document
.... 7.7 CMC eCTD SP4151 Document
.... 7.8 Component Substance
.... 7.9 Document Reference Attachment
.... 7.10 Drug Product Component
.... 7.11 Drug Product Container Closure
.... 7.12 Drug Product Description
.... 7.13 eCTD Product Description and Composition
.... 7.14 eCTD Specification Composition
.... 7.15 eCTD Substance Control of Materials Composition
.... 7.16 eCTD Substance General Information
.... 7.17 Excipient Drug Substance
.... 7.18 Manufactured Drug Product
.... 7.19 Polymorphic Form
.... 7.20 Quality Specification
.... 7.21 Routine Drug Product
.... 7.22 Routine Drug Substance
.... 7.23 Substance General Information
.... 7.24 PqAddress
.... 7.25 Additional Information
.... 7.26 Container Closure
.... 7.27 Content Percent
.... 7.28 Hierarchical Level
.... 7.29 Interpretation Code
.... 7.30 Optional Denominator
.... 7.31 Profile IG Version
.... 7.32 Specification Type
.... 7.33 Strength Extension
.... 7.34 Test Order | Stage Sequence Order
.... 7.35 Capsule Shell Classification Terminology
.... 7.36 Chemical Structure Data File Type Terminology
.... 7.37 Closure Type Terminology
.... 7.38 Coating Purpose Terminology
.... 7.39 Code System PQCMC Product Characteristic
.... 7.40 Conformance to Criteria Terminology
.... 7.41 Container Type Terminology
.... 7.42 Drug Product Component Function Category Terminology
.... 7.43 Drug Route Of Administration Terminology
.... 7.44 eCTD sections Terminology
.... 7.45 Excipient Function Terminology
.... 7.46 Ingredient Location Terminology
.... 7.47 Interpretation Code Terminology
.... 7.48 Manufactured Dose Form Terminology
.... 7.49 Name Part Terminology
.... 7.50 Organization-Site Identifier Terminology
.... 7.51 Pharmaceutical Dosage Form Terminology
.... 7.52 Product Name Types Terminology
.... 7.53 Product Part Type Terminology
.... 7.54 Quality Benchmark Terminology
.... 7.55 Relationship Types Terminology
.... 7.56 Release Mechanism Terminology
.... 7.57 Release Profile Terminology
.... 7.58 Source Type Terminology
.... 7.59 Specification Status Terminology
.... 7.60 Specification Type Terminology
.... 7.61 Strength Operator Terminology
.... 7.62 Strength Type Terminology
.... 7.63 Substance Classification
.... 7.64 Substance Name Type
.... 7.65 Test Category Terminology
.... 7.66 Test Method Origin Terminology
.... 7.67 Test Usage Terminology
.... 7.68 Units Of Measure Terminology
.... 7.69 Code System PQCMC Comp Section Types
.... 7.70 Hierarchical Test Category Codes
.... 7.71 PQ-CMC-FDA Temporary Codes
.... 7.72 Product Name Types Code Types
.... 7.73 Relationship Types Codes
.... 7.74 278736ef-2ddf-49e4-895c-3a9f34db36cf
.... 7.75 7cdbb042-9275-4599-a1fe-08877846bf94
.... 7.76 A DrugProductContainerClosure
.... 7.77 A DrugProductDescription for a multilayer product
.... 7.78 A FinishedProduct profile based on ManufacturedItemDefinition
.... 7.79 A quality specification is for a drug product
.... 7.80 A quality specification is for a drug substance
.... 7.81 Base64 Document Reference - L-thyroxine-3D-structure-CT1000583834.sdf
.... 7.82 Base64 Document Reference - Levothyroid.png
.... 7.83 Base64 Document Reference - Monosodium_D-thyroxine_hydrate.png
.... 7.84 Bundle for 3.2.S.1
.... 7.85 Carrageenan specification Example
.... 7.86 Citric acid specification Example
.... 7.87 CMCeCTDDocument32P10 bundle
.... 7.88 Cochineal specification Composition Example
.... 7.89 Cochineal specification Example
.... 7.90 Composition ingredient substance indentifying information - acetaminophen
.... 7.91 Composition ingredient substance indentifying information - aspirin
.... 7.92 Composition ingredient substance indentifying information - Maize starch
.... 7.93 Drug Manufacturing Site - Vandechemie
.... 7.94 drug product for specification
.... 7.95 Drug Substance Nomenclature and Structure
.... 7.96 DrugProductComponent example for an excipient - Maize starch
.... 7.97 East-West Manufacturing
.... 7.98 eCTD Composition for 3.2.S.1
.... 7.99 eCTD Document for 32S23
.... 7.100 eCTD Drug Substance Specification Composition SP4151
.... 7.101 eCTD Product Specification Composition SP4151
.... 7.102 EctdComposition32P10 for 2 layer tablet
.... 7.103 Example Composition for CTD 3.2.S.2.3
.... 7.104 Example of a Supplier Organization
.... 7.105 Example of MfgTestSiteOrganization profile on Organization
.... 7.106 Example RoutineSubstanceDefinition - IBUPROFEN
.... 7.107 Example RoutineSubstanceDefinition for Asprin
.... 7.108 Example SubstanceDefinition for anhydrous citric acid
.... 7.109 Example SubstanceDefinition for Carrageenan
.... 7.110 Example SubstanceDefinition for water
.... 7.111 FHIR Document example of 3.2.P.4.1.
.... 7.112 FHIR Document example of 3.2.P.5.1.
.... 7.113 IngredComponentSubstance example showing the use of the sourceMaterial backbone element
.... 7.114 Manufacturing Site (J. Jones Research)
.... 7.115 Polymorphic Form Example
.... 7.116 Sponsor of API
.... 7.117 SponsorOrganization - Wunderwerke
.... 7.118 SponsorOrganization J. Jones Research
.... 7.119 Strength info for the Active Ingredient
.... 7.120 Strength information - Grape skin extract
.... 7.121 Strength information for the Active Ingredient - acetaminophen
.... 7.122 Vidinaid
.... 7.123 Water Specification Example
... 8 Downloads
... 9 Change Notes