Q13 Continuous Manufacturing of Drug Substances and Drug Products
Q13 EWG Continuous Manufacturing of Drug Substances and Drug Products
This topic was endorsed by the Assembly in June 2018. This new Guideline is proposed to:
- Capture key technical and regulatory considerations that promote harmonisation, including certain Current Good Manufacturing Practices (CGMP) elements specific to Continuous Manufacturing (CM),
- Allow drug manufacturers to employ flexible approaches to develop, implement, or integrate CM for the manufacture – drug substances and drug products – of small molecules and therapeutic proteins for new and existing products,
- Provide guidance to industry and regulatory agencies regarding regulatory expectations on the development, implementation, and assessment of CM technologies used in the manufacture of drug substances and drug products.
Date of Step 2b: 27 July 2021
Status: Step 3
Endorsed Documents (Click the links below for complete guidelines)
Guidelines (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
