FDA Guidance for Industry: ICH Q12: Implementation Considerations for FDA-Regulated Products
Title:
FDA Guidance for Industry: ICH Q12: Implementation
Considerations for FDA-Regulated Products
Origin/Publisher:
FDA
Content:
The International Council for Harmonisation (ICH) guidance for industry Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes (ICH Q12, May 2021) provide a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient
manner.