PERFORMANCE VALIDATION (P1V)


Shown as the seat of performance validation.

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.


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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.

P1V 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.

The normal expectations for P1Q are given as requiring, documented verification that facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification. Onto that now should be grafted The verification that the all the requirements specified in the User Requirements Specification (URS) have been fully complied with.

The P1Q represents the final qualification of your equipment or system. This incorporates a range of testing to simulate your production process options and provide assurance that your systems and your operating documentation, are capable of subsequent process validation activities. It is used to establish and or confirm;

  1. Definition of performance criteria and test procedures.
  2. Selection of critical parameters, with predefined specifications.
  3. Determination of the test intervals, e.g.,
    (a) - Everyday.
    (b) - Every time the system is used.
    (c) - Before, between and after a series of runs.
  4. Define corrective actions on what to do if the system does not meet the established criteria.


Validation Online document package users confirm that they do routinely - Experience a 70% reduction in the cost of preparing validation plans and protocols - Also - Experience an 80% reduction in the time required to incorporate review comments: - Also - Experience a 95% reduction in the time required to raise supplementary protocols that are routinely required to plug omissions: - Also - Experience a 72% reduction in the time taken in getting their validation tasks to the execution of protocol stage - Also - Experience much greater confidence that their validation task will be completed within time and budget estimates - So keep in mind that. - Using a validation package will ensure your validation task is properly defined, assessed, scoped and subjected to the appropriately intensity of qualification.

Performance Validation Relationships.

This graphic is a schematic of the inter-relationships of P1V documentation.

PERFORMANCE VALIDATION



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Validation Master Plan (Issue 8) -- $115.00

The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable cGMP requirements as specified in 21 CFR Part 11, 210, 211 and 820 into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks.  It must mandate the production of all Practices and Procedure manuals and SOP's.

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Validation Plan (Issue 10) -- $93.00

The VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes.  It is a master reference for all validation variables and queries.

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Validation Risk Assessment (Issue11.) -- $125.00

When you declare that your validation is Risk based; then it is incumbent on you to use a suitable tool to convert the perceived level of risk to an appropriate intensity of validation.  This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.  This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance rulings.

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 Package for Equipment Validation Level-2. (Issue 3) -- $585.00

During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task.  The use and scope of the individual documents has been documented, discussed and explained in detail.  It is therefore obviously best policy to have in place exactly what the regulator is looking for.  The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated

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