These combination IQ-OQ-PQ protocols have 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. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The Installation Qualification (IQ) section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The Operational Qualification (OQ) section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The Performance Qualification (PQ) section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the User Requirements Specification (URS).
This combined IQ-OQ-PQ protocol contains over seventeen fully detailed test scripts along with the methodology for twenty more compliance tests and inspections. It has been collated from the three individual templates and incorporates sufficient inspections and test stages to ensure that the equipment under qualification has been properly installed, 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 re-qualification 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 Test Specification (FTS) 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.
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 why not ask about validation time line savings made 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 - one IQ-OQ-PQ protocol to circulate for reviewing.
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.
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.
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This 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. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.