PERFORMANCE VALIDATION (P1V)

Performance Validation Rationale

The scope of the Performance Validation (P1V) (the 1 or 2 is used to negate confusion between P1V (Performance Qualification) and P2V (Process Qualification)).

P1Q is performed after successful completion of the Installation qualification (IQ) and Operational Qualifications (OQ) execution. The testing carried out is targeted at verifying that the performance specified in the URS is being delivered. Verification is also required to confirm the requirements specified in cGMP’s, health and safety rules and other guidance documents. Test objectives, acceptance criteria and methodologies must all be specified and pre-approved. 

On satisfactory conclusion of P1Q the equipment is usually handed over to production and in association with QA/QC the process is validated using the P2Q protocols.

Performance Validation Scope.

The Performance Qualification can be used to verify that the equipment executes correctly and consistently throughout the range of parameters that the process requires or the Performance Qualification can be used to verify that the equipment executes correctly throughout its entire design range.

PQ activities are conducted on critical systems, and demonstrate (and document) that the equipment is able to perform its intended functions within the variable process limits for a specific product.  Acceptance criteria are developed according to the regulatory requirements and production parameters to ensure that the quality and purity of the product is maintained.

Performance Qualification testing includes, but is not limited to, activities such as sterilization/sanitization.  Usually (not a mandatory requirement as long as your method is justified and documented) a minimum of three successful consecutive test runs are required for this purpose. The PQ process may also include several challenges to the system challenging the operating limits, i.e., not "to failure". This testing provides confidence that the equipment will function properly during reasonable adverse conditions.

PQ standards are very equipment and process specific. Specifications will be found in the individual standards sections. The PQ's require replicate testing; with triplicate testing as the generally accepted minimum. The PQ will also test the extremes of the operation, or the peak load conditions, but it does not include testing to failure.