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Process Validation
Purpose
To establish documented evidence which provides a high degree of assurance that the production process will consistently produce a product meeting its pre-determined specifications and quality attributes. It is to distinguish between “prospektiv”, “retrospektiv” and “concurrent” process validation.
Prerequisites
  • Validation / qualification system (SOPs) should be in place
  • All the equipments, production environment and utilities (HVAC, purified water, compressed air, etc) have been fully qualified.
  • All the quality critical measuring instruments have been calibrated.
  • Analytical methods have been validated.
  • Master and batch production instructions are available, up to date and approved
  • Staff taking part in validation work should have been appropriately trained.
  • Discussions with client are required throughout the whole validation process.
Procedures
  1. Discuss with client about their requirements and collect the required information for quotation (Signing of Secrecy Agreement recommended).
  2. Prepare an offer (fixed rate difficult, depends on the process and process steps).
  3. Sign the contract and project commence.
  4. Nominate a Validation Team.
  5. Prepare a Validation Master Plan (VMP).
  6. Prepare basic SOPs for process validation if not yet available
  7. Perform a risk assessment (FMEA, HACCP or other type) to define the critical steps to be validated and the critical parameters (etc) to be monitored.
  8. Prepare a Project Plan Validation (PPV).
  9. Prepare Validation Protocols and SOPs for approval by client.
  10. Collect all records and data of the last 20 to 30 batches and check and evaluate the predefined critical parameters in case of a retrospective validation
  11. Train the production staff based on the validation protocol (prospective validation)
  12. Production staffs in manufacturer perform the production runs for prospective or concurrent Process Validation and generate the batch records, analytical records and printouts.
  13. Discuss the results within the validation team and evaluate all deviations
  14. Prepare the Validation Report for approval by client.
  15. Compile all the relevant documents in the Validation Master File.
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