Process Validation vs Verification...
Information | Understanding | current Best Practice.When to Validate. When to Verify. Validation vs Verification.
Validation vs Verification: Where the results of a process cannot be fully verified by subsequent inspection and test, and that process influences critical attributes of a product or process, then the process should be validated with a high degree of assurance and approved according to established procedures.How do I know if a process cannot be fully Verified?
If clinical or destructive testing is necessary to show a process produces the desired result, (for example, testing package seals) then on-going verification will not be practical. Where routine end-product testing does not examine all quality attributes of the finished product or has insufficient sensitivity to verify the desired safety and efficacy of the finished product, (for example the visual examination of a weld), then again verification may not be acceptable or practical.The decision matrix shown can help explain the decision process between the need for validation versus verification. In the decision process, both quality and cost considerations are taken into account. Can the output of a process be fully verified without validating? If yes, then verification alone may be acceptable to the organization. However, will the on-going operating cost of verification be acceptable?
Alternatively, if the output of a process cannot be fully verified via some form of on-going inspection and testing, then validation will be necessary.
Product and Process Validation.
Information | Understanding | current Best Practice >>>
The validation versus verification decision can also be based on organizational policy. It may be an approach of the organization to validate change where not strictly necessary in order to facilitate improved process understanding, or to facilitate reductions in future levels of in-process testing. For example, the results of a process may be fully verifiable via subsequent testing, however, organizational policy may be to move away from in-process and final testing towards high stability, low variability processes, with minimized levels of inspection and testing. In this approach, there will be a continuous push for higher levels of validation as a means of reducing future operating costs and variability reduction.
Examples of processes that would normally be validated:
• Sanitation• Sterilization
• Sterile filling
• Filling, capping, sealing
• Fumigation
• Fermentation
• Clean rooms
• Cleaning
• Bulk production
• Purification
• Sterile packaging sealing processes
• Lyophilization
• Depyrogenation
• Heat treating
• Plating
• Plastic injection molding
• Welding
Examples of processes that may need validation:
• Certain human assembly processes• Numerical control cutting processes
• Filling processes
Examples of processes that may be verified:
• Manual cutting processes• Testing for color, turbidity, total pH for solutions
• Visual inspection of printed circuit boards
• Manufacturing and testing of wiring harnesses
Product and Process Validation.
- The Validation Master Plan. Performing a Gap Analysis. Validation in the Design Process. Etc..
- How to ensure Validation efforts are aligned with potential Risks.
- How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
- Information | Understanding | current Best Practice >>>