REFERÊNCIAS:
.-EMA: Questions and answers: Good manufacturing practice – Data Integrity Section
.-FDA: FDA Data Integrity Guidance
.-MHRA: MHRA Data Integrity Definitions and Guidance
.-PIC/S: PIC/S Guidance
.-WHO: WHO Guidance
Artigos recentes
- Framework for the Use of Digital Health Technologies in Drug and Biological Product Development
- Advancing regulatory science in the EU – mid-point report published
- Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
- Gestão de Risco no âmbito das Boas Práticas de Distribuição : “Formação muito bem conseguida com aplicabilidade prática”
- EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME : Audit Checklist
- MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
- Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*
- Artificial Intelligence in Drug Manufacturing.