During this phase product design specifications are transferred to production and the production processes are established to support volume manufacturing. Following process validation, the manufacturing of commercial product can commence, scaling up to meet commercial volume requirements.

The transfer to production activities include:      *outsourced

  • Establishment of manufacturing and inspection specifications and procedures
  • Establishment of routing / bill of materials / DMR
  • Process risk analysis (FMEA)
  • Process validation planning (MVP)
  • Process validation execution (IQ/OQ/PQ)
  • Sterilisation validation*
  • Product microbial monitoring schedule (bioburden/LAL)
  • Operator training / certification