The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.
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Recentes
- Considerations for Complying With 21 CFR 211.110 Guidance for Industry
- Final version of its Guideline for Good Clinical Practice E6(R3). Adopted on 6 january 2025
- New EU rules for health technology assessments become effective
- ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions Step 5
- Inter-association joint position paper on Electronic Product Information
- MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
- Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway