PERFORMANCE QUALIFICATION Template (PQ).
Performance Qualification template Compiling.
Performance Qualification template 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 template.
Performance Qualification template Rationale.
The scope of the P1Q (the 1 or 2 is used to
negate confusion between Performance Qualification template 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 template (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.
PQ Scope.
The normal expectations for Performance qualification template (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 performance qualification template 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 template 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.
Performance Qualification Template Relationships.
12000068 FAT_SAT_SOP
This combination document gives you basically 2 for 1 value. The Factory Acceptance Testing (FAT) and the Site Acceptance Testing (SAT) are very closely related. In the 'FAT' instance (which should be executed in the suppliers establishment), all aspects of design will be verified for compliance with the cGMP functionality specified in the URS. Completion and approval of the FAT, should allow shipment to point of use to be made. The SAT, must replicate the FAT plus all the additional test and inspections that are required to verify that all the 'installation specifications' as documented in the URS, have been fully satisfied. It is essential that the FAT is used to verify that all aspects of the performance Qualification template specified in the URS are working as specified, before the equipment is verified as ready for commissioning and then validation.
Combined IQ-OQ-PQ Equipment. (Issue-7)
This three-part, cGMP compliant, protocol template will arrive with you: fully detailed, with all test scripts, rationales and test methods laid-out in accordance with regulatory expectations. First issued as an equipment-validation document; end-user demand quickly forced us into widening the scope of IQ-OQ-PQ (formated protolcols - click to view).
This combined IQ-OQ-PQ protocol along with the appropriate interrelated plans and assessment documents will not only validate the item under qualification, but it will also ensure that the detailed audit trail needed to meet all internal or external regulatory reviews and or inspections is produced.
Design Qualification (Issue
The Standard Operating Procedure attached to this generic design Performance qualification Template, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained
VrrP_Equipment
Issue - 4.
This Validation Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. Resulting in the document becoming notably easier to use and quicker to review and amend. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
12000006_4Q_Equip
Issue - 4.
4Q Equipment Validation4u Protocol (4Q-Equip) has been designed
specifically to replace four standard protocols. By taking the
contents of the four protocol and carefully weaving them into one notably easy
to use protocol, we have made a significant advance in the task of streamlining
validation4u documentation by reducing protocol numbers by close to 75%. The
new bang up to date 4Q protocol replaces the DQ, IQ, OQ & Performance qualification template P1Q) and now
compliments our equally new VrrP Protocol. By integrating the old style
DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in
the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word and compliant with FDA GMP Part 11 legislation.
12000008 4Q Equip Package
This quite unique two
document package is all that is required to fully validate; to cGMP standards,
equipment used in a regulated facility. A lot of effort has gone into ensuring
that repetitive instructions and actions have been designed out and innovative
and intuitive risk-based methodologies have been incorporated.
Both documents are prefaced with a methods' Standard Operating Practice (SOP)
document. These SOP’s lead you through the task of converting these highly
detailed templates into your very own company bespoke protocols. The hyperlinks
and cross-references within the package are; not only unique but also highly
cost-effective and intuitive to use. Each document is preloaded with the test
scripts (complete with acceptance criteria). All test and inspection scripts
are written in MS word, to facilitate simple editing of text, layout, tables
and schematics and are compliant with FDA GMP Part 11 regulations.