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

Table of Contents

Page standards status: Informative
.. 0 Table of Contents
... 1 Home
... 2 General Instructions
... 3 General Information (3.2.S.1)
... 4 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
.... 10.34 eCTD Product Description and Composition
.... 10.35 eCTD Specification
.... 10.36 eCTD Substance Characterisation
.... 10.37 eCTD Substance Control of Materials
.... 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 Overage 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 Percentage Units
.... 10.71 Pharmaceutical Dosage Form Terminology
.... 10.72 PQCMC Name Part Terminology
.... 10.73 Product Name Types Terminology
.... 10.74 Product Part Type Terminology
.... 10.75 Quality Benchmark Terminology
.... 10.76 Release Mechanism Terminology
.... 10.77 Release Profile Terminology
.... 10.78 Representation Types
.... 10.79 Source Type Terminology
.... 10.80 Specification Section Type Terminology
.... 10.81 Specification Status Terminology
.... 10.82 Specification Type Terminology
.... 10.83 Strength Type Terminology
.... 10.84 Structure Data Types
.... 10.85 Substance Classification
.... 10.86 Substance Name Type
.... 10.87 Test Category Terminology
.... 10.88 Test Method Origin Terminology
.... 10.89 Test Usage Terminology
.... 10.90 Units Of Measure
.... 10.91 PQ-CMC-FDA NCIt Hierarchy Supplement
.... 10.92 3.2.P.1.0 Bundle
.... 10.93 3.2.P.3.2 Bundle for liquid
.... 10.94 3.2.P.3.2 Bundle for two-layer tablet
.... 10.95 3.2.P.4 Bundle
.... 10.96 3.2.P.5.1 Bundle
.... 10.97 3.2.P.5.5 Bundle
.... 10.98 3.2.P.5.5 Bundle 2
.... 10.99 3.2.S.1 Bundle
.... 10.100 3.2.S.2.3 Bundle
.... 10.101 3.2.S.3 Bundle
.... 10.102 3.2.S.4.1 Bundle
.... 10.103 SDF File in a Structure Reference
... 11 Downloads
... 12 Change Notes