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What is GMP DMF/CoS/CMC GAP Analysis Process Validation Qualification Training
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Cleaning Validation
Purpose
To establish documented evidence which provides a high degree of assurance that the individual cleaning processes will consistently reduce the impurities to a predefined value which assures that there is no detrimental impact on the product produced or handled within the cleaned equipment.
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.
  • Analytical methods have been validated (including Detection Limit and Quantitation Limit).
  • Master and batch production instructions are available, up to date and approved.
  • Cleaning 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 products, the number of cleaning processes and equipments).
  3. Sign the contract and project commence.
  4. Nominate a Validation Team if not set up.
  5. Prepare a Validation Master Plan (VMP) if not existent or make an update.
  6. Prepare basic SOPs for cleaning validation if not yet available.
  7. Perform a risk assessment (FMEA, HACCP or other type) to define the critical cleaning processes and equipments to be validated and the critical parameters and check points (etc) to be monitored.
  8. Prepare a Project Plan Validation (PPV) if not existent or make an update.
  9. Prepare Validation Protocols and SOPs for approval by client.
  10. Train the production staff based on the validation protocol.
  11. Production staffs in manufacturer perform the Cleaning Validation and generate the cleaning records, analytical results and printouts.
  12. Discuss the results within the validation team and evaluate all deviations.
  13. Prepare the Validation Report for approval by client.
  14. Compile all the relevant documents in the Validation Master File.
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