Combined IQ/OQ/PQ Protocol

The Installation Qualification Section of combination IQ OQ PQ establishes documented qualification 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 2" of combination IQ OQ PQ Template establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary qualification evidence to demonstrate this. The Performance Qualification (PQ) "section 3" of combination IQ OQ PQ template  gives documented verification that the equipment performance in its normal operating environment is consistently "exactly as specified" in the User Requirements Specification (URS).

Combined IQ/OQ/PQ 1946

These IQ OQ PQ template contains over seventeen fully detailed qualification test scripts along with the methodology for twenty more compliance tests and inspections. It has been collated from the three individual IQ OQ PQ template 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 qualification protocol standards.  If a little time was spent on revamping these test documents standards, (changing the templates would only have to be done once) a format could be used that would enable all such testing to be included in any qualification online 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 online protocols,  as an alternative to repeating all the IQ OQ PQ Template associated qualification testing. This would result in the in a much better under standing of how to produce a superb combined IQ OQ PQ Protocol at greatly reduced cost.

 Click here to view the FDA, WHO & EU requirements for protocol testing formats that should be used for IQ OQ PQ template wording.

Combined IQ/OQ/PQ 3785

All of our three part combined IQ OQ PQ template and it must be understood that comprehending; How to produce a superb combined IQ OQ PQ Protocol, can be made easy with the correct introduction to a common standard with the layout, introduction and table of contents being precisely and repeatable similar.
While all the test and inspection stages are purposely targeted at the validation online requirements of the specific item under qualification.

The IQ section of the combined IQ OQ PQ template contains all the standard qualification inspections and tests that you would include in a stand-alone Installation Qualification Protocol for the same equipment. The Operational Qualification section of the combined IQ OQ PQ template in a similar manner contains all the standard tests and inspections that are usually included in a stand-alone OQ protocol and the Performance Qualification section follows the same pattern.

All three IQ OQ PQ protocol 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 online time-line savings made in using these three part protocols ?  Which are still held as three separate tasks (for compliance purposes); but are published as one document (for cost effectiveness).  I.E. One introduction to be edited.  One rationale to be edited - Test scripts all written up for you - One document to be circulated for peer review - One document  to be approved and printed. Only one document to be managed and maintained through from conception to execution and through change control and on into archive.

The case for the combined IQ OQ PQ template qualification protocol is very compelling.

Consider 10 items requiring validation qualification that means it could be just ten IQ OQ PQ template as opposed to thirty 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 qualification document.

Combined IQ/OQ/PQ 3725

Understanding how to produce a superb combined IQ OQ PQ Protocol is really easy when it is prefaced by a 10 page SOP, which enables you to follow the SOP instructions and progressively (page by page) convert this your fully detailed template into a superb Combined IQ OQ PQ protocol.

These protocol templates are targeted at equipment and are suitable for all equipment from the laboratory to the process line. All standard verification's are already included in the protocol format and all test scripts are fully documented and referenced.

Validation Online documents should never be confused with the routine document templates available on the internet. These templates are mainly little more than a list of chapter headings. Where as, Validation Online documents are of a unique interactive design which has been developed over the last ten years. Ten years during which regulatory compliant documentation has been successfully supplied to over sixty countries.

The theme of how to produce a superb combined IQ OQ PQ Protocol was developed by a team of pharmaceutical consultants working across the pharmaceutical, medical device and bio-technical industries. These consultants covered all the validation disciplines and collectively pondered long and hard to come up with a design that would be acceptable to all users and highly cost effective for companies.

Now this new combined IQ OQ PQ Template protocol brings a refreshingly simple and attractive approach for the industry professional, enabling them to raise professional quality validation online protocols in a very efficient and cost effective manner.

Combined IQ/OQ/PQ/ Protocol 9945

The following method of construction must be used in the; how to produce a superb Combined Protocol. The over-all protocol standards are shown in the SOP’s for the different protocols, here we are concerned about the testing element alone. All testing must be detailed and pre-approved by a qualified person to ensure the system under test has been adequately tested. Each test must comprise of;

Main Sub-headings in Test Script.

1. A Rationale; giving the reason and or object of the test.
2. A Detailed Test Method.
3. A Detailed Acceptance Criteria.
4. A Test Result (did test result satisfy the acceptance criteria)

General details that must be adhered to.

1. The test result must be initiaied (or signed) by the person executing the tests, on completion or at each significant stage.
2. Training given for understanding the intricacies of how to produce a superb combined IQ OQ PQ Protocol.
3. Each test must be designed to verify an element of the equipment functionality.
4. Each test must a have a result that is clear, unambiguous and known.
5.  The test method must call up for the recording of the test result parameters. (no ticks or tick boxes, no generalities).
6.  Each test in this combination IQ OQ PQ Template protocol must be witnessed or the results must be reviewed by a competent person.
7. The overall test results must be approved by a competent person.