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 Performance Validation protocol the equipment is usually handed over to production and in association with QA/QC the process is validated using the P2Q protocols.
The Performance Validation 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 Validation 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, repetitively and in accordance with approved process method and product specifications. Onto that should be grafted The verification that the all the requirements specified in the User Requirements Specification (URS) have been fully complied with.
The Performance Validation1Q 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.
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;
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. 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 infringing regulatory standards.
4Q Equipment Validation 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 validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ 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 ease of editing; it is still written in word.