Representative Qualification

GOOD VALIDATION PRACTICE (cGVP)
1

Good Afternoon;

I need some advice. I have been asked to put together a proposal for representative qualification of the equipment in our facility. Basically, we have alot of old, identical equipment that has not been qualified. We want to use specific equipment items to be “worst-case” representatives of a particular equipment grouping, test these and use their compliance to requirements (assumptions always) to cover the entire equipment group they represent. I have a clear idea in my head of what could be done (Example, IQ all 7 Grals, but OQ/PQ the 2 worst-case items based on age, performance, maintenance history, etc). However, I would like to know if there are any references that I could utilise to expand further on this.

Any assistance would be highly appreciated!!!

2

I worked on a similar project last year with identical equipment.

Our approach was quite similar we IQ’ed all the identical pieces of equipment and did recuded testing on the OQ section of the validation (We decided there was no value in performing PQ testing)

In terms of reference material I have not read any material with such a scenario, I suppose experience is the best reference point.

If you take this approach make sure you document your justification, the VP might be a good place to explain what approach you are taking.

Hope this helps

3

Thanks Graham, really appreciate it! I was worried about where the justification would reside, guess the VP is as good a place to start as any…With regard to the PQ, would we take a sort of retrospective qualification approach? Since the equipment has been pumping out product day in day out for the last 5 - 15 years, could we conduct a product review instead of performing a PQ?

Regards

Marwaan

4

A retrospective qualification would be better than a product review as it would complete the documentation set nicely, you could incorporate this product review into the PQ.

Just a thought

5

Was thinking along those lines a little earlier, about an hour after posting. Basically review the equipment history and associated documents, locking those down.

Thanks Graham, you’ve been of great assistance…

6

No problem