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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- Study supporting the monitoring of the availability of medical devices on the EU market. 2 July 2026
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- MHRA Open consultation Draft rare disease therapies regulatory framework
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- Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples