Validation

We draw up and implement qualification protocols valid for all processes and the activities carried out on the pharmaceutical production plant: Process Validation, Equipment Validation, Utilities Validation, Computer System Validation, Cleaning Validation, Analytical Method Validation, in accordance with the GMP (Good Manufacturing Practice), ICHQ14 and GAMP (Good Automated Manufacturing Practice) guidelines, always with a view to using the data in the implementation of digital processes.

  • cGMP Compliance of computerized control systems and Data Integrity
  • CSV (Computer system Validation)
  • Elaboration and implementation of qualification protocols
  • Process validations
  • FMEA
  • Process Analytical Technology (PAT) Support
  • Implementation of IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Perfomance Qualification) protocols and Witnessing of Supplier Testing Activities (FAT/SAT support)
  • cGMP Compliance of critical utilities
  • cGMP Compliance of the Cleaning Validation of materials and excipients
  • cGMP Compliance of the packaging processes,
  • cGMP Compliance of Quality Control laboratories and Validation of Sterile and Non-sterile forms
  • Technology Transfer
  • Validation Master Plan
  • Quality Risk Management
  • Media Fill Protocols
  • Commissioning Plan
  • Packaging Process Validation
  • Transport Validation
  • Shipping validation
  • Mapping temperature
  • Elaboration of documents and SOPs
  • System supplier audits
  • Support for validation periodic review