VALIDATION & GMP SERVICES

Validation & gmp services

Our offer of validation services performed by our team of specialists.

Range of application: isolators, glove boxes, pass boxes, hoods, ovens, filters, dispensing systems, HVAC / cleanroom system.

Documents Drafting & development

  • User Requirements Specification (URS)
  • Validation Master Plan & Project Plan (VMP/VPP)
  • Specification Documentation (FS)
  • Standard Operating Procedures (SOP)
  • FAT / SAT Protocols
  • IQ / OQ / PQ Protocols
  • P&Id
  • Requalification, Calibration, and Maintenance Protocols
  • Summary Reports
  • Design of production/areas according to GMP

Validation process

  • Thermal mapping of production areas
  • Risk assessment
  • Execution of FAT, SAT, IQ, OQ, PQ protocols.
  • Gap analysis

For any information: office@ammoimaging.com