PERFORMANCE QUALIFICATION (PQ).


Performance validation customer city skylines. this one is New York.

Performance Qualification Compiling.

Performance Qualification compilers 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.


PQ Rationale.

The scope of the P1Q (the 1 or 2 is used to negate confusion between Performance (P1Q) and Process P2Q) Qualifications.
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.

Performance Qualification (P1Q) is often used to qualify equipment throughout the full range of the equipment capabilities ,as opposed to process qualification, that is only concerned about capabilities that the process under validation uses.



PLEASE CLICK HERE AND GO TO OUR STORE.



PQ Scope.

The normal expectations for P1Q are given as requiring, documented verification that facilities, systems and equipment, as connected together, can perform effectively and repetitively, 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;

  • Definition of performance criteria and test procedures.
  • Selection of critical parameters, with predefined specifications.
  • 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.
  • Define corrective actions on what to do if the system does not meet the established criteria.

PQ Relationships.

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

PERFORMANCE QUALIFICATION.



Search Our Store

To find a specific document enter full details in Search Box Below. The more defined the search is the more precise the search findings will be.



Select Preferred Language


When assistance is required; please contact us on TOLL-FREE 877-462-4048

If out of office hours; please leave a voice message.


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.

Quantity

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.

Quantity


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.

Quantity


 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

Quantity