ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Chemistry, Manufacturing, And Controls (CMC), Pharmaceutical Quality
Published
May 20, 2021
Last updated
September 10, 2021
Description
Draft guidance document by FDA on implementation considerations for FDA-regulated products, focusing on Chemistry, Manufacturing, and Controls (CMC) and Pharmaceutical Quality.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)