Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Guideline

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.

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