Module 3qualityndaind

3.2.P — Drug Product

Drug product quality information: composition, development, manufacture, control, stability

Requirements by Phase

Phase 1

required

Phase 2

required

Phase 3

required

NDA

required

Drug product quality information: composition, development, manufacture, control, stability

Requirements by Phase

IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required

Content (NCE/Small Molecule)

Complete drug product quality documentation covering description, development, manufacture, control of excipients, control of drug product, reference standards, container closure, and stability

Expected Deliverables

Drug product quality dossier (Module 3.2.P)

ICH Guidelines: Q6A, Q6B, Q8

Regulatory Requirements (FDA IND PHASE 2 3 CMC)

[All] Certain information traditionally submitted in information amendments, identified as corroborating information, can be submitted in an annual report.
[Phase 2] Limited phase 2 corroborating information recommended in section III need not be submitted before initiation of phase 2 studies and can be generated during phase 2 drug development.
[Phase 3] Phase 3 corroborating information recommended in section IV need not be submitted before the initiation of phase 3 studies and can be generated during phase 3 drug development.
[All] Corroborating information and a summary of CMC safety information submitted during a subject-reporting period should be included in the annual report, eliminating the need for general CMC updates at the end of phase 1 or phase 2.
[All] CMC safety information should be submitted to support the safe use of the drug.
[Phase 2] The CMC safety information identified in section III (Phase 2 Studies) should be submitted before initiation of the phase 2 studies.
[Phase 3] The CMC safety information identified in section IV (Phase 3 Studies) should be submitted before initiation of the phase 3 studies.
[All] When new information becomes available that relates to the safe use of the drug or when there are changes in previously submitted CMC safety information, it should be submitted during IND clinical trials in an information amendment.
[All] For changes with a significant potential to affect the safety of the product, an information amendment should be submitted describing the changes and containing relevant information at a level of detail sufficient for an adequate review and assessment.
[Phase 2] Corroborating information specified in section III (Phase 2 Studies) that is generated during phase 1 need not be submitted until the first annual report after initiation of phase 2 studies.
[Phase 2] Corroborating information specified in section III (Phase 2 Studies) that is generated during phase 2 studies should be submitted in the next annual report after the information becomes available.
[Phase 3] Corroborating information specified in section IV (Phase 3 Studies) that is generated earlier during phase 1 and phase 2 need not be submitted until the first annual report after initiation of phase 3 studies.
[Phase 3] Corroborating information specified in section IV (Phase 3 Studies) that is generated during phase 3 studies should be submitted in the next annual report after the information becomes available.
[Phase 2] Updates on the brief description of the drug substance and a more detailed description of the configuration and chemical structure for complex organic compounds should be provided.
[Phase 2] The addition, deletion, or change of any manufacturer of the drug substance from that specified during phase 1 should be reported.

Source: ICH Q8(R2); ICH Q6A; 21 CFR 312.23(a)(7)(ii)

References

ICH Q8(R2)ICH Q6A 21 CFR 312.23(a)(7)(ii)

Sections

3.2.P.1 — Description and Composition

Description of dosage form and quantitative composition including overages

3.2.P.2 — Pharmaceutical Development

Development of dosage form, formulation, manufacturing process, container closure, and microbiological attributes

3.2.P.2.1 — Components of the Drug Product

Drug substance compatibility with excipients, excipient choice rationale

3.2.P.2.2 — Drug Product

Formulation development, overages justification, physicochemical/biological properties

3.2.P.2.3 — Manufacturing Process Development

Manufacturing process development and optimization studies

3.2.P.2.4 — Container Closure System

Suitability of container closure system for its intended use

3.2.P.2.5 — Microbiological Attributes

Microbiological attributes of the dosage form including preservative effectiveness

3.2.P.2.6 — Compatibility

Compatibility with reconstitution diluents and dosing devices

3.2.P.3 — Manufacture

3.2.P.3.1 — Manufacturers

Name, address, responsibility of each drug product manufacturer

3.2.P.3.2 — Batch Formula

Batch formula including all components and their amounts per batch

3.2.P.3.3 — Manufacturing Process and Controls

Flow diagram and narrative of drug product manufacturing process with critical steps

3.2.P.3.4 — Controls of Critical Steps

In-process controls for critical manufacturing steps

3.2.P.3.5 — Process Validation

Process validation and/or evaluation for drug product manufacturing

3.2.P.4 — Control of Excipients

3.2.P.4.1 — Excipient Specifications

Specifications for each excipient used in the drug product

3.2.P.4.2 — Excipient Analytical Procedures

Analytical procedures for testing excipients

3.2.P.4.3 — Excipient Validation of Analytical

Validation of analytical procedures used for excipient testing

3.2.P.4.4 — Excipient Justification of Specifications

Justification for excipient specifications not based on pharmacopeial standards

3.2.P.4.5 — Excipients of Human or Animal Origin

Information on excipients derived from human or animal sources (TSE risk assessment)

3.2.P.4.6 — Novel Excipients

Full safety data package for novel excipients not previously used in approved products

3.2.P.5 — Control of Drug Product

3.2.P.5.1 — Drug Product Specification

Drug product release and shelf-life specifications

3.2.P.5.2 — Drug Product Analytical Procedures

Analytical procedures for drug product testing

3.2.P.5.3 — Drug Product Validation of Analytical

Validation of drug product analytical procedures

3.2.P.5.4 — Drug Product Batch Analyses

Batch analysis results for clinical and development batches

3.2.P.5.5 — Characterisation of Impurities

Identification and characterization of degradation products in the drug product

3.2.P.5.6 — Justification of Specification

Scientific rationale for drug product specification and acceptance criteria

3.2.P.6 — Reference Standards

Reference standards or materials used in drug product testing

3.2.P.7 — Container Closure System

Description and suitability of container closure system for the drug product

3.2.P.8 — Stability

3.2.P.8.1 — Stability Summary

Drug product stability summary and conclusions on storage conditions and shelf life

3.2.P.8.2 — Post-Approval Stability Protocol

Post-approval stability protocol for drug product ongoing monitoring

3.2.P.8.3 — Stability Data

Drug product stability data from long-term, accelerated, and stress conditions

Related Sections

Up toModule 3: Quality

3.2.S — Drug Substance

Drug substance quality information: characterization, manufacture, control, reference standards, stability

3.2.A — Appendices (Quality)

Quality appendices for biotech products: facilities, adventitious agents, novel excipients

3.2.R — Regional Information

Region-specific quality information (executed batch records, comparability protocols, methods validation)

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