Equipment CQV

Design → Build → Test → Operate → Maintain

• URS & Design Qualification

  • GMP-critical requirements

  • Process linkage (CPPs → CAs → URS)

• FAT / SAT

  • Vendor protocol review & execution

  • Data integrity & deviation handling

• Commissioning

  • Pre-qualification readiness

  • Turnover packages

• IQ / OQ / PQ

  • Risk-based testing

  • ASTM E2500 leverage

• Bioreactors (single-use & stainless)

• Seed trains & media prep systems

• Disc-stack centrifuges

• Chromatography skids & columns (UNICORN)

• UF/DF systems

• Buffer prep & hold tanks

• CIP/SIP systems