What are the cGMP requirements for documentation?

Женщина-исследователь смотрит на пробирку с жидкостью
  • All documents reviewed and approved by a cross-functional team of experts (quality, operations, etc.)
  • Traceability thanks to continuous filing of records during the manufacturing process and archiving them for 15+ years after product expiration
  • Procedures reviewed periodically to ensure latest versions are used