General Quality Assurance and Quality Management Systems
Quality Assurance and GMP compliance of pharmaceuticals (all dosage forms)
- Batch record review in accordance with Annex 16 EU GMP
- Change control management
- Deviation & CAPA management
- Preparation of Product Quality Reviews (PQRs)
- Preparation and review of GMP-relevant documents (SOPs, WIs,…)
- Risk assessment and risk management
- Process validation
Codes, regulations & guidelines: EU GMP (EudraLex – Volume 4), ICH Quality Guidelines, AMG/AMWHV, CFR (Title 21, Parts 210, 211)
Regulatory bodies: BfArM, EMA, MHRA, FDA