Informative thread to the future of validation

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Taken from the yahoo discussion group
Informative thread to the future of validation


I have been in this group for several years and have posted very few times, only when I felt that I could offer some thought-provoking commentary. I have read the discussion about the qualifications and I think that there has been a lot of thought from some very gifted minds into the proper naming convention for documents, the proper way of completing all the installation and operational testing required to meet cGMPs and how to make all of this fit into a nice, tidy validation package (I said nice and tidy, I did not say small).

In my humble opinion, it appears that the FDA is trying to push the industry into a new mode, where the “validation package” is weighted much more on the front end design than ever before in their history. The IQ, OQ, PQ (I will state that I have not executed a PQ in several years…) are still in place, but their makeup is changing to be quite different than what they were composed of years ago. Yes, the FDA has been saying “build quality into” processes and systems for years, but until recently, they have not been very open in providing assistance in how to make this happen. I think that we are now giving that guidance and hoping to see more of it happen in the industry.

There have been many “new” ideas in validation over the years, I remember once reading an article from a validation person that stated if a validation is properly executed and a good preventive maintenance plan is in place, that there should theoretically be no need for online testing. The risk was extremely low that the system would perform outside its validated parameters and there was little risk to the product. The PAT applications will perform automated online testing to verify that the system is performing within its validated (qualified?) parameters at all times, so does that reduce the level of risk to the product that we no longer need a 6000 page validation package that contains various IQ, OQ and PQ tests? Hmmmmmmmm

The risk of manufacturing adulterated product is certainly reduced to almost nil if a qualified PAT application is in place, is measuring the correct CQAs in the manufacturing process and is providing that feedback to the
controller. I agree that validation will never go away, but I do think it will
evolve quite a bit - the ICH Q8 guidance defines continuous process verification as “an alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated.” And Q8 is an accepted FDA guidance, published by the FDA in May of 2006 (if memory serves me correctly). Powerful stuff, eh?

I am sorry that I am running so long, just wanted to state that there is
change in the industry with the publication of Pharmaceutical cGMPs for the 21st Century, PAT, Q8, Q9, Q10, even the ISPE’s C&Q guidelines and many other documents out there. I have studied them, not at great length, but enough to know that they are all very much inter-related and they are all pointing towards a new way of “validating” processes, and this new way of doing business is looked upon with great favor by the FDA. We should start thinking about what validation will look like in the future rather than defining it in the present or past.

I know, this is a Part 11 group and I have been discussing validation, but I had a thread that lead me here, so I claim it is a just e-mail. And,
speaking of Part 11, I do not think that the new Part 11 guidance is a top priority with the FDA as it is just going through the legal mumbo jumbo now, I believe that the agency feels that the industry is implementing Part 11 in the manner that was expected back in 1997.

I thank you for your time on this subject and look forward to opinions
(agreeing and dissenting).


Hi Graham,

I working ias a Regulatory consultant, currently in a project for a Contact Research Org, involved in clincal trials.

I am working on the validation for the systems and applications of the CRO, i am looking for a Validation template. Are there any freedownlaods available so that i can customise for my requirements


Thanks in advance,