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.
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.
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;
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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. This is an essential step forward for companies seeking to reduce validation costs without sacrificing regulatory compliance.
This new 4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the these four protocols and carefully weaving them into one notably easy to use protocol, we have made significant progress in reducing validation paperwork. Reductions of up to 75% have been quoted as the likely total. Integrating the old style DQ/IQ/OQ/PQ protocols into one 4Q document will be an enormous savings in man hours in the authoring, reviewing, updating and approving tasks. With the simultaneous introduction of the new Validation risk & Requirements Plan (VrrP) which integrates the VP, VRA & URS into one document - equipment validation has been reduced to two document.
This quite revolutionary 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.
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