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View Full Version : Process Validation example wanted MBeth 18th November 2008, 09:28 AM I am in desperate need of an example of a process val protocol and example... I saw the example in the GHTF link, which is a great start, but can anyone help with more? I am fine on IQ/OQ but the PQ is tough for me.... thanks, my friends:thanx: Ajit Basrur 18th November 2008, 10:08 AM I am in desperate need of an example of a process val protocol and example... I saw the example in the GHTF link, which is a great start, but can anyone help with more? I am fine on IQ/OQ but the PQ is tough for me.... thanks, my friends:thanx: Can you decsribe your process to get better responses ? MBeth 18th November 2008, 10:12 AM My company is a contract manufacturer for medical devices. Mainly they are CNC operations and passivation. I have just started, so my knowledge of their processes are a trifle limited. Any examples are appreciated. achorste 18th November 2008, 12:27 PM Hi MBeth - I also work for a medical device contract manufacturer (forging, casting, machining & sub-contracted cleaning / sterilisation) OQ we challenge worst case parameters, but for PQ we normally launch 3 batches of the largest & 3 batches of the smallest products in the range (batch sizes to reflect normal production), ensure they are processed on different shifts (or a day apart from each other) with normal production controls etc. This tests repeatability in the normal production enviroment & repeatability between operators as well. Hope this helps.... MBeth 18th November 2008, 12:43 PM Definitely a help; thanks. do you have an actual template or example of your protocol and/or report? Thanks achorste 18th November 2008, 01:05 PM Sure, it is a current one I am drafting - I've cleaned it up a bit & removed any sensitive info, but I think you can get the gist... Let us know if there's anything you don't understand. MBeth 18th November 2008, 01:33 PM It's PERFECT! Exactly the kind of help I needed! I am so grateful, especially for your quick response. You can have a great day, knowing you did a good deed for a lady in distress. :agree1: achorste 18th November 2008, 01:55 PM Just glad I could help! :D Weiner Dog 2nd December 2008, 11:16 AM Just as a side- don't forget about FDA's 21 CFR 820.250 & ISO 13485 8.1, 8.2.3, 8.2.4, 8.5 statistical technique sections. The old "3 batch" rule no longer applies- unless one can prove so scientifically. Doug Tropf 2nd December 2008, 12:01 PM Just as a side- don't forget about FDA's 21 CFR 820.250 & ISO 13485 8.1, 8.2.3, 8.2.4, 8.5 statistical technique sections. The old "3 batch" rule no longer applies- unless one can prove so scientifically. ISO 11135-1:2007 still makes references to 3 runs during validation activities. |
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