PERFORMANCE VALIDATION



Performance Validation Rationale.

This image represents a medical device and these devices are subjected to many forms of performance validation.

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.


Go to Shop for details of Performance Validation documentation.


Performance Validation Scope.

Performance validation is performed to verify that the performance available is equal to or better than, the performance specified in the final User Requirements Specification.


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.


PERFORMANCE VALIDATION



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.



12000002_Validation_Risk
Requirements_Plan_(VrrP)

$299.00

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.



12000006_4Q_Equip_Protocol. (4Q-Equip). $299.00

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.