Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0-ballot: STU2 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 General Information (3.2.S.1)
... 4 Substance Control of Materials (3.2.S.2.3)
... 5 Substance Characterisation (3.2.S.3)
... 6 Specification (3.2.S.4.1, 3.2.P.4 and 3.2.P.5.1)
... 7 Description and Composition of the Drug Product (3.2.P.1)
... 8 Product Batch Formula (3.2.P.3.2)
... 9 Product Characterisation of Impurities (3.2.P.5.5)
... 10 Artifact List
.... 10.1 Analysis Graphic
.... 10.2 Analytical Instrument Data
.... 10.3 Attached Document (PDF)
.... 10.4 Document Reference Attachment
.... 10.5 Graphic Reference
.... 10.6 Literal Coded Reference
.... 10.7 Literal Reference
.... 10.8 PQCMC Attachment
.... 10.9 Structure Data
.... 10.10 Structure Data Reference
.... 10.11 Text Only Codeable Concept
.... 10.12 Basic Organization
.... 10.13 Batch Formula Drug Product Identification
.... 10.14 CMC eCTD 32P10 Document
.... 10.15 CMC eCTD 32P32 Document
.... 10.16 CMC eCTD 32P55 Document
.... 10.17 CMC eCTD 32S10 Document
.... 10.18 CMC eCTD 32S23 Document
.... 10.19 CMC eCTD 32S3 Document
.... 10.20 CMC eCTD SP4151 Document
.... 10.21 Component Substance
.... 10.22 ContainerClosure
.... 10.23 Drug Product Batch Formula
.... 10.24 Drug Product Batch Formula Ingredient
.... 10.25 Drug Product Component
.... 10.26 Drug Product Description
.... 10.27 Drug Product Handle
.... 10.28 Drug Product Impurities
.... 10.29 Drug Substance
.... 10.30 Drug Substance Handle
.... 10.31 Drug Substance Impurity
.... 10.32 eCTD Batch Formula
.... 10.33 eCTD Product Characterisation of Impurities Composition
.... 10.34 eCTD Product Description and Composition
.... 10.35 eCTD Specification Composition
.... 10.36 eCTD Substance Characterisation
.... 10.37 eCTD Substance Control of Materials Composition
.... 10.38 eCTD Substance General Information
.... 10.39 Excipient Drug Substance
.... 10.40 Manufactured Drug Product
.... 10.41 Polymorphic Form
.... 10.42 Quality Specification
.... 10.43 Substance General Information
.... 10.44 PqAddress
.... 10.45 Additional Information
.... 10.46 Amount Ratio
.... 10.47 Hierarchical Level
.... 10.48 Product Batch Ingredient Extension
.... 10.49 Product Batch Strength Textual Extension
.... 10.50 Specification Status
.... 10.51 Strength Extension
.... 10.52 Target Range
.... 10.53 Analytical Instrument Data File Types
.... 10.54 Batch utilization Terminology
.... 10.55 Capsule Shell Classification Terminology
.... 10.56 Chemical Structure Data File Type Terminology
.... 10.57 Closure Type Terminology
.... 10.58 Coating Purpose Terminology
.... 10.59 Container Type Terminology
.... 10.60 Drug Product Component Function Category Terminology
.... 10.61 Drug Route Of Administration Terminology
.... 10.62 eCTD sections Terminology
.... 10.63 Excipient Function Terminology
.... 10.64 GENC and ISO 3166 Intersection
.... 10.65 Graphical File Types
.... 10.66 Impurity Classification Terminology
.... 10.67 Ingredient Location Terminology
.... 10.68 Manufactured Dose Form Terminology
.... 10.69 Non-Percentage Units
.... 10.70 Organization-Site Identifier Terminology
.... 10.71 Percentage Units
.... 10.72 Pharmaceutical Dosage Form Terminology
.... 10.73 PQCMC Name Part Terminology
.... 10.74 Product Name Types Terminology
.... 10.75 Product Part Type Terminology
.... 10.76 Quality Benchmark Terminology
.... 10.77 Release Mechanism Terminology
.... 10.78 Release Profile Terminology
.... 10.79 Representation Types
.... 10.80 Source Type Terminology
.... 10.81 Specification Section Type Terminology
.... 10.82 Specification Status Terminology
.... 10.83 Specification Type Terminology
.... 10.84 Strength Type Terminology
.... 10.85 Structure Data Types
.... 10.86 Substance Classification
.... 10.87 Substance Name Type
.... 10.88 Test Category Terminology
.... 10.89 Test Method Origin Terminology
.... 10.90 Test Usage Terminology
.... 10.91 Units Of Measure
.... 10.92 PQ-CMC-FDA NCIt Hieararchy Supplement
.... 10.93 32532fe8-1bfb-4a0a-998d-9294742a9519
.... 10.94 7cdbb042-9275-4599-a1fe-08877846bf94
.... 10.95 9e8f2d16-66b1-47ec-878d-f50ae021985b
.... 10.96 Bundle for 3.2.S.1
.... 10.97 CMCeCTDDocument32P10 bundle
.... 10.98 de75e338-626c-4503-a25d-4fcdd8e39bee
.... 10.99 eCTD Document for 32S23
.... 10.100 Example Batch Formula bundle
.... 10.101 Example Batch Formula bundle with two layers
.... 10.102 FHIR Document example of 3.2.P.5.1.
.... 10.103 FHIR Document example of 3.2.S.4.1.
... 11 Downloads
... 12 Change Notes