Development of IOQ protocols - Validation in the pharmaceutical industry

[Twigs85]

Hi,

i have recently been made redundnen due to Motorola pulling out of Ireland. I am now studying validation as the pharmaceutical industry is strong in Ireland while most of the software jobs are rapidly moving east to cheaper markets. For one of my validation modules I need to develop an IOQ protocol. I have designed the index based on classes to date and hints from our tutor as to what might be required.

I am wondering if anyone could provideme with a sample IOQ or even and OQ protocol to help me establish how it all hangs together, how things are phrased etc ..

Any help would be greatly appreciated. Here is my index so far -





1. Title Page
2. Document History (revision details)
3. Protocol Approval Sections (define in responsibilities section)
4. IOQ Protocol Objective
5. Scope – define the physical boundaries and the extent of qualification effort
• Include P&ID and direct impact ‘bubble’ on P&ID
• Reference the system impact assessment
• Reference the component impact assessment (Lesson 6)
• Include a table of operationally critical components (include a rationale column as to why it is operationally critical (sentence for operationally critical only))
• Reference completed requirements traceability matrix (include some text describing the process)
6. IOQ Protocol Pre-requisites (ensure commissioning is finished etc)
7. Discuss format of summary report to this IOQ protocol (all tests have successfully passed, all deviations and changes are closed and a declaration that the system is fit for purpose)
8. WIP System Description (High Level)
9. Document References
• VMP
• P&ID
• General design documents (isometrics, flow diagrams etc)
• Other design documents
10. Responsibilities (be sure to define actual roles – who is responsible for signing what?)
11. Generally describe use of project deviation procedure (paragraph) – include a blank generic deviation form and associated log as an attachment
12. Generally describe use of project change control procedure (paragraph) – include a blank generic change control form and associated log as an attachment
13. General document procedure (GDP) – good documentation practices (include high level detail)
• Describe training requirements necessary for individuals necessary to execute the protocol
14. DQ Completion Certificate

15. Installation Qualification Checks (must capture all direct impact components)
• P&ID Walkdown sheet
• Equipment checks
• Instrument Checks (loop checksheet for operationally critical components – loop cal sheet)
• Piping Checks (general installation type tests, reference weld logs for verification of material of construction, no weld logs required)
16. Progress from IQ to OQ approval – QA sign off IQ before OQ executed
17. Operational Qualification Checks
• Base it on all operationally critical components identified – Baseline Guide 5
• SOPs
• Various OQ Tests
18. Signature log (include text – what is it for, who signs it….?)
19. Deviation Log
20. Deviation Form
21. Change Control Log
22. Change Control Form
23. Preventative Maintenance Verification Checksheet
24. Site Instrument Calibration Log
25. Test Instrument Calibration Log (instruments used during IQ/OQ)
26. List of SOPs – the SOPs that need to be in place to operate the system, and keep system in validated state (hypothetical list)
27. Training Log – one list for training on validation exercise (e.g. SOP training and IOQ execution training)
28. Glossary / List of abbreviations

[BradM]

Well, hello there!

Welcome to the Cove, and I am really sorry that I have not replied sooner.

I was wondering if we could still be of some assistance. Have you made some progress on your documentation?

[aqajrc]

Hello,

The GLobal Harmonization Task Force has a very good guidance document for IQ OQ PQ on their Study Group 3 webpage http://www.ghtf.org/sg3/inventorysg3...0_edition2.pdf SG3/N99-10 (Edition 2)Quality Management Systems - Process Validation Guidance

Hope this helps,

Best regards,