IQ/OQ/PQ Literature - Learning and implementing IQ/OQ/PQ procedures at my facility

R

RIPNBST

#1
Hello all, new member here. Not 100% sure if this is the right forum for this topic. If there is a more appropriate place that I overlooked, mods please feel free to relocate me and I apologize in advance.

I have been tasked with learning and implementing IQ/OQ/PQ procedures at my facility and have little to no experience with the IQ/OQ/PQ process. I have worked within PPAP systems before and my current employer operates under ISO 9001 as well as (soon to be certified) AS 9100. We also make medical device components and that industry is the driver behind our want to implement our own interpretation of IQ/OQ/PQ for new equipment in our manufacturing facilities.

Does anyone have any books that they have read or used for reference when learning/implementing IQ/OQ/PQ procedures that they might recommend? Most of the ones I have found are related to biopharmaceutical use. I am trying to find a book that may be more general in its application examples and terminology. We are looking to implement the IQ/OQ/PQ methodology for installation of new manufacturing equipment in our production area.

I did find a book titled "Validation and Qualification in Analytical Laboratories" but I'd rather not spend a hundred dollars of my companies money only to find it's not helping. Again, if anyone has any recommendations I am all ears. Thanks in advance for any help you may be able to lend.
 
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#3
Re: IQ/OQ/PQ Literature - Learning and implementing IQ/OQ/PQ procedures at my facilit

I have seen several good example in this site, I would encourage you to use the search function. Cheers!
 
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