Guideline on Post Approval Change Management of Pharmaceutical Manufacturing Process(Guidance for industry)
- Registration Date 2024-12-23
- Hit 665
In order to provide an easy-to-understand explanation of the required documents and types of change management for quality and equivalence assessments associated with post-approval changes, we have prepared and published an English version of the 'Guidelines on Post Approval Change Management of Pharmaceutical Manufacturing Process (Guidance for Industry)' to support domestic and international manufacturers in managing changes to manufacturing process for pharmaceuticals.
Attached File
Attach all down
-
Guideline+on+Post+Approval+Change+Management+of+Pharmaceutical+Manufacturing+Process(Guidance+for+industry).pdf Download
Division 의약품규격과
Written by 이태웅
Telephone 043-719-2964