Best Practice in Process Validation

I

irelandoem

Hi All,

I'm trying to put together a validation system and protocols based on best practice. I have gone through as much guidance as I can find, FDA, GHTF etc. and soon will be visiting our multinational customers to ask questions.

So I'm looking for suggestions on what are the right questions to ask. So far I have:

General introductory questions
? Can you give an overview of the equipment qualification process in your organisation
? In qualifying equipment we say that the equipment is ready for its intended use. What criteria would you require for 'ready'?
? Do you think the equipment qualification process provides an effective framework for assessing quality issues?
? Do you think the equipment qualification process provides an effective framework for addressing safety issues?
? Do you think the equipment qualification process provides an effective framework for addressing maintenance issues?
? Do you think the equipment qualification process provides an effective framework for addressing reliability issues?
? What do you think are the key elements for the equipment qualification process
? In your experience, is a systematic or ?case by case? approach used
- What standards, guides or procedures are used to develop EQ
? Are the following techniques used in the EQ process? If so, how?
o FMEA
o HAZOP
o Total Productive Maintenance

Equipment Qualification Prerequisites
? What documents / analysis must be completed prior to the equipment qualification process?
Prompts:
o User Requirement Specifications
o Risk Assessments
o FATs/SATs
o Supplier Evaluation

Installation Qualification
? What documents do you refer to in writing IQ protocols
? What checks are performed at the Installation Qualification stage
Prompts:
o Utilities
o Environmental considerations
o Ergonomics / Human Factors
o Health & Safety
o Maintenance
o Calibration

Operational Qualification
? What documents do you refer to in writing OQ protocols
? What checks are performed at the Installation Qualification stage
Prompts:
o Functional Testing
o Alarms & limits
o Data connections
o Utility Failure
o Verification that ?supporting? processes can be performed (e.g. equipment adjustment and cleaning)
o ?Worst Case? testing
o Process Capability
o Process characterisation / optimisation
 DOE
 Response surface
Performance Qualification
? What documents do you refer to in writing PQ protocols
? What checks are performed at the Installation Qualification stage
o Sampling Plan
o Process Capability
o Documentation ? Standard Operating Procedure

General closing questions

? How do you think the equipment qualification process could be improved?


thanks guys!
 

yodon

Leader
Super Moderator
A few (random) thoughts...

IQ/OQ/PQ is only a de-facto standard; not required. If they validate using a different approach, as long as the bases are covered, it should be ok.

Do they have a validation master plan (VMP or MVP)? Recognize that validation isn't a 1-time event. Stuff happens after validation that can push the equipment out of a validated state. Controls need to be in place to assess the changes and take appropriate actions to maintain the validated state (up to and including re-validation).

If there is software in the system, is that validated? If the software uses COTS, how is it managed?

When you get down to performance qualification, do they have a statistically based plan or do they fall back on 3 runs? Increasingly, inspectors are looking for statistical significance in qualification and rejecting results that aren't based on statistical principles.

Those jump to mind; plenty others, no doubt.
 
I

irelandoem

yodon, thanks a mil for your contribution. Whereas I had been concentrating on the efforts to establish confidence in the equipment/process, you have shown the importance of maintaining the validated state.
the software is one aspect I certainly hadn't considered, thanks again.
 
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