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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- IMDRF Document Implementation Report
- Acceptable Media for Electronic Product User Manuals
- FDA final guidance on ‘Electronic Submission Template for Medical Device De Novo Requests’
- Cyber security in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings
- ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
- EUDAMED user guide NRDs (Custom made and Old devices) for the Vigilance module
- MDSAP AUDIT APPROACH UPDATED. Revision Date: 2024-08-06.