https://www.slideshare.net/DrAmsavelvel/validation-master-plan-115143205
Performance Qualification authors 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 performance qualification.
The scope of the P1Q (the 1 or 2 is used to negate confusion between Performance Qualification (P1Q) and Process Qualification (P2Q).
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.
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 qualification 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.
[https://www.validation-online.net/performance-qualification.html]
For example, a performance qualification might demonstrate:
- That a system can handle multiple users without significant system lag
- That when the system contains large quantities of data, queries are returned in a certain (short) period of time
- That concurrent independent work-flows do not affect each other
- That a laboratory test correctly identifies a known material
- That a process was completed within defined system requirements
https://www.youtube.com/watch?v=fL5wE097yqU
