IQ OQ PQ PROTOCOLS.


IQ OQ PQ extremely popular comprehensively detailed template for both medical devices and pharmaceutical use with the FDA, WHO & EU..


Introduction to the Requirement..

This combined IQ OQ PQ protocol was specifically designed to be used for stand-alone equipment.  This combination protocol consists of three protocols which collectively have approximately thirty inspections or tests that must be executed to verify that the equipment under qualification is used, operates and performs in a manner that satisfies all the appropriate requirements as detailed in the relevant User Requirements Specification (URS), cGMP’s and your company practices and procedure rulings.

All companies carryout routine calendar based qualification and requalification functional testing of stand-alone laboratory type equipment.  Unfortunately most of this testing is documented in a manner that is not compatible with basic FDA, WHO & EU validation protocol standards.  If a little time was spent on revamping these test documents standards, (changing the template would only have to be done once) a format could be used that would enable all such testing to be included in any validation requirement.


Since regulators already accept the concept that unnecessary retesting should be avoided whenever possible. It follows that since all other tests in our protocols are fully written up, if the routine functional testing was of the right format then a recently executed routine or commissioning test could be reviewed and commented on in any validation protocols,  as an alternative to repeating all the associated testing. This would result in the time line and cost of validation for this equipment being greatly reduced.

Click here to view the FDA, WHO & EU requirements for protocol testing formats and wording.


Click on the link below to view the range of protocols that are available in our combined IQ/OQ/PQ format.

Combined IQ/OQ/PQ tripartite format.


Welcome to the home of IQ OQ PQ validation protocols.

 

Please click on the appropriate link below for details of the any individual IQ, OQ OR PQ protocol template you require.

 

Validation Master Plan.

 

Validation Plan.

 

Design Qualification.

 

User Requirements Specification.

 

Installation Qualification.

 

Operational Qualification.

 

Combined IQ-OQ-PQ Qualification.

 

Performance Qualification.

 

Process Qualification.

 

Or the associated tools:

 

Vendor Audit

 

SOP for cGMP 

 

SOP for Writing SOP

 

Gap Analysis

 

Perhaps you do not want a template.  If you require a protocol bespoke to your requirement and ready to use, please click below:

 

Bespoke Ready to Use Protocols.

 

If the document you want is not listed here please look in our document store:

 

Document Store

 


Benifits of Using Tripartite Format.

All our three part combined IQ/OQ/PQ protocols are written to a common standard with the layout, introduction and table of contents being very similar.  While all the test and inspection stages are purposely targeted at the validation requirements of the specific item under qualification. 

The IQ section contains all the standard inspections and tests that you would include in a stand-alone IQ for the same equipment.  The OQ section in a similar manner contains all the standard tests and inspections that are usually included in a stand-alone OQ protocol and the PQ follows the same pattern.  All three sections contain spare test script pages; that can easily be edited to suit any specific additional tests that may be required. 

So what do I save in using these three part protocols?

One introduction to be edited.  One rationale to be edited.  Test scripts all written up for you.  One document to be circulated for review.  One document to be edited - post review -. 

Only one document to be managed and maintained through from conception to execution and through change control and on to archived. 

Consider 10 items requiring validation that means it could be just 10 protocols as opposed to 30 to write, review, edit and approve. Make no mistake; reviewing and approving documents is always the task that is least planned for and subsequently often a serious bottle neck in achieving time line requirements.

Note:-  Most editing is interactive, i.e. entering the basic data once (Company name/equipment details, etc.) immediately inserts the entered data throughout the whole document.


IQ OQ PQ


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Procedural Documentation


Validation Master Plan (Issue 7) -- $115.00

This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols and is a great document to author and use. This document interfaces with our Validation Risk Assessment  (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

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Validation Documentation Matrix (Issue 6.) -- $29.00

This Matrix must sit along-side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to all the associated documents; the A to D prefix shows the progress stage.

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Validation Plan (Issue 8) -- $89.00

This document follows our well-developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

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SOP for Equipment Validation (Issue 6.) -- $22.00

This Standard Operating Procedure (SOP) takes you through the validation process for equipment, from the very early first stages to the final closing stage. It will ensure that your validation is seamless, that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important risk assessments. There are ever-increasing demands on the Biotechnology and Pharmaceutical industries to meet increasing regulatory and legislative requirements, whilst improving the performance and efficiency of the business. This SOP shows the way to streamline your validation while still being fully compliant. Easing and smoothing the production and flow of protocols, so decreasing costs and delivering validation ahead of schedule. It is essential material for the new comer to validation and will direct you flawlessly through all validation tasks. For the company it is an essential SOP to add to the library. For your convenience it is written in word.

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