Editing Performance Qualification Template into a Protocol.

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 image refers to performance qualification software used in continuous production processes.

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.

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This image is inserted to ensure readers of this performance qualification protocol are correctly informed.

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.

This graphic is a schematic of the inter-relationships of performance qualification documentation.

PERFORMANCE QUALIFICATION.

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.


Combined IQ/OQ/PQ for Spreadsheets. (issue-2) $159.00

This combination protocol has been specifically designed to verify that all aspects of your spreadsheet conform to best practice and that the spreadsheet layout ensures consistent and accurate use and results. The tests and inspections normally authored in separate protocols have been assembled in one protocol which is divided into three sections. This protocol enables you to verify that your developed spreadsheet application is GMP compliant, thus avoiding 483s and warning letters. You can now validate your application with minimal documentation. Equipment Validation Protocol, validation protocol template.


Design Qualification (Issue 5) -- $115.00

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.


Combined IQ-OQ-PQ Equipment. (Issue-8)  $159.00

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.