PQ/CMC structuring and standardization is intended to be accomplished in multiple phases. For the first phase, the Agency has focused on some of the sections of ICH eCTD that will provide the foundation for future phases.
- Phase 1 covers the following topics: Drug Product, Drug Substance, Quality Specification, Batch Formula, Batch Analysis and Stability.
- Phase 2 data standards are under development, and will cover the following topics: Drug Product Manufacturing, Drug Substance Manufacturing, etc.
The Phase 1 data elements are grouped logically into domains. The table below shows how the logical groups align with the ICH eCTD Module 3 sections. The structured data elements and the supporting proposed terminology for these Phase 1 domains has been published by the FDA in Federal Register Notice(s).
|ICH eCTD Section Names
|ICH eCTD (v 3.2.2) Module Sections
|Nomenclature and Structure
|Control of Materials
|3.2.S.2.3; 3.2.S.2.4 (for intermediates ONLY)
|Characterisation - Elucidation of Structure and other Characteristics
|Characterisation - Impurities
|Description and Composition
|Control of Excipients - Specifications
|Characterisation of Impurities
|Quality Specification for Substance & Product
|Specification (includes Text and Acceptance Criteria)
|Batch Analysis for Substance & Product
|Batch Analysis and Batch information
|Stability for Substance & Product
Table 1: PQ/CMC Phase 1 Group alignment to ICH eCTD Module 3 Sections
FDA’s PQ/CMC Data Standards development effort is an iterative process. The eCTD sections identified in the table above are some of the sections that FDA is structuring in early iterations. There are plans to review and structure other sections within this Phase in the near future.
- For additional information/support from PQ/CMC Team, please contact PQ-CMC@fda.hhs.gov.