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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- BOAS PRÁTICAS de FARMACOVIGILÂNCIA : ” Formação completa, contempla os pontos principais de Boas Práticas de Farmacovigilância “
- New EMA GMP Guidelines in the next three Years : The 3-year work plan for the Inspectors Working Group
- Formação QUALITY MANAGEMENT SYSTEM: ” Ótima forma de rever temas e aprofundar conhecimentos com casos do dia -a-dia “
- C(2026) 1809 expands the list of Class IIb implantable devices exempt from the obligation to perform an assessment of technical documentation for every device under Article 52(4).
- EU PARLIAMENT Textes Adopted on AI – 26/03/2026 Simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
- Registo Investigação e Tratamento de RECLAMAÇÕES : “Muito útil para melhorar os processos já implementados “
- ISO 20417:2026 – Updated Guidance on Medical Device Information – The second edition of ISO 20417:2026 (Medical devices – Information to be supplied by the manufacturer) has just been published.
- COMMISSION DELEGATED REGULATION (EU) …/… amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations C/2026/1798 final