Services

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