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.
- Applying in parallel with an EU marketing authorisation application
- Notified bodies’ audits performed in the context of quality management system assessment
- FORMAÇÕES 2021 : CREDITAÇÕES PELA ORDEM DOS FARMACÊUTICOS.
- Calendário de formações 2021
- IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Update dec 2020
- Register medical devices to place on the market
- 14ª Edição da formação sobre as BPD: “Uma revisão abrangente da temática ,que combina a legislação com casos práticos”
- Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025