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Related Topic Tags
fda (food and drug administration), installation qualification (iq), language issues, operational qualification (oq), performance qualification (pq), ppap (production part approval process), medical devices (general)
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  #1  
Old 23rd January 2009, 01:04 PM
wslabey wslabey is offline
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Please Help! IQ, OQ, PQ (installation, operational & performance qualification) compared to PPAP

How does IQ, OQ, PQ compare to PPAP? Our company is moving into life sciences and producing FDA exempt products that will be used in laboratories. Our suppliers speak in the language of IQ, OQ, PQ and PPAP is foreign to them.

Are they comparable? If so, has anybody done a comparison. I would deeply appreciate a posting that answers my questions. Thanks in advance for your help.

Bill

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Old 23rd January 2009, 05:39 PM
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Re: IQ, OQ, PQ compared to PPAP

I haven't seen a comparison that I remember. The weekend is starting so if no one replies bump this thread next Monday morning and you'll probbly get a reply.

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Old 23rd January 2009, 08:25 PM
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Re: IQ, OQ, PQ compared to PPAP

PPAP & IQ OQ PQ are quite different, I'm not sure if a direct comparison can me made. IQ OQ PQ validates a process, typically this is individual processes, although it is sometimes used as a basis to validate full manufacturing routes.

IQ OQ PQ doesn't call for process capability or gauge studies specifically but there's no particular reason why they can't be included. (Gauge studies may be required in IQ for new gauging methods)

IQ OQ PQ, as your may have inferred from the name comes in three stages:

IQ - installation qualification
OQ - operational qualification and
PQ - performance qualification

IQ - verify the equipment is installed correctly, training, utilities, could include DoE for new unfamiliar processes, SOPs, risk analysis, preliminary control plans etc etc

OQ - testing "worst case parameters" - basically define the worst case settings for the particular process and ensure it still gives acceptable results - i.e. for an ultrasonic cleaner it could be lowest temperature, lowest frequency and lowest solvent concentration.

PQ - this ensures the process is repeatable - to do this you would have to define a statistically relevant number of production runs of typical batch / lot sizes. Although often I used the "three batch rule" - running 3 batches of the largest & smallest parts in a product range. The 3 batch rule isn't recognised offically anywhere as far as I know. This is all done under normal manufacturing conditions - i.e. no special inspection - everything as it would be in full production.

I posted the GHTF (Global Harmonisation Taskforce validation guidance the other day here: http://elsmar.com/Forums/showpost.ph...94&postcount=2 This gives the recommended guidelines for process validation.
Thank You to achorste for your informative Post and/or Attachment!
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Old 15th March 2010, 01:35 PM
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Re: IQ, OQ, PQ (installation, operational & performance qualification) compared to PP

Talk about a time delay. I appreciate the response. I am from an automotive background and work for an automotive supplier of engineering services, prototyping, and low volume production. Like many suppliers we are diversifying and have acquired a small startup company in Life Sciences. That division is moving along ISO 13485 registration with a scope that is limited to marketing and design. Its designs are made by contract manufacturers. I have learned a bit about IQ, OQ, PQ but I feel the quality deliverables I have seen from contract manufacturers are not concise or complete at each phase of the IQ, OQ, PQ. I would like to bring the discipline of PPAP with its deliverables (i.e., an all in one package) to our production approval process including engineering approval and validation of production run parts.

Any thoughts or comments would be most appreciated.

Bill
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Old 16th March 2010, 05:49 AM
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Re: IQ, OQ, PQ (installation, operational & performance qualification) compared to PP

Hi Bill,

I come from the medical devices industry.

I know you're talking about ISO 13485, but I just realized that in FDA (QSR) terms, your lifescience company may qualify as a specification developer. As such, I'm not sure that they are even required to have process validation; it may be the contract manufacturer's responsibility. While this maybe true for medical devices, I am less sure wrt pharmceticals (which also fall under "lifescience").

In MDD terms (which are more closely related to ISO 13485) they might suffice with an annex VI (product final inspection) conformity, leaving the whole actual production as a "black box".

Cheers,
Ronen.

Quote:
In Reply to Parent Post by wslabey View Post

Talk about a time delay. I appreciate the response. I am from an automotive background and work for an automotive supplier of engineering services, prototyping, and low volume production. Like many suppliers we are diversifying and have acquired a small startup company in Life Sciences. That division is moving along ISO 13485 registration with a scope that is limited to marketing and design. Its designs are made by contract manufacturers. I have learned a bit about IQ, OQ, PQ but I feel the quality deliverables I have seen from contract manufacturers are not concise or complete at each phase of the IQ, OQ, PQ. I would like to bring the discipline of PPAP with its deliverables (i.e., an all in one package) to our production approval process including engineering approval and validation of production run parts.

Any thoughts or comments would be most appreciated.

Bill
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Old 4th September 2010, 08:48 AM
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Re: IQ, OQ, PQ (installation, operational & performance qualification) compared to PP

I am taking PPAP as meaning - Production Part Approval Process. As such it applies to a production part. Where as pharmaceutical / biotechnical / medical device cGMP

http://www.accessdata.fda.gov/script...t=820&showFR=1

regulations apply not only to the product, but also all the manufacturing / testing / packaging / utilities / facilities / environmental / recording equipment, along with all associated processes that are used to produce test and store, the product.

There is no doubt you will have much of the required information to hand, but is it in an acceptable format? Many industries accept the likes of tick boxes (to indicate compliance), this practice is proscribed by our regulators. All tests must start with a rationale (justifying the test). Then contain a detailed test method. Then continue with a detailed acceptance criteria. Then complete with your test results and a statement that the acceptance criteria was or was not satisfied.

There is a strict regime of documentation that must be sequential in execution.

Alex Kennedy
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Old 4th September 2010, 09:08 AM
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Re: IQ, OQ, PQ (installation, operational & performance qualification) compared to PP

Quote:
In Reply to Parent Post by alex.Kennedy View Post

<snip> If you go to: <snip>
Alex, do you have an association with/interest in the web site you posted a link to?

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Old 4th September 2010, 09:54 AM
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Re: IQ, OQ, PQ (installation, operational & performance qualification) compared to PP

Yes and No.

However the answer to the query would have been long winded, where as the process is described in detail on the web page I referenced. This is in the free document guidance section, and there is no sales made from these pages. The other reference was to the actual FDA regulation.

When someone was stuck not long ago you asked me to post a reference to the required information. Which I did and which appeared to be acceptable to your forum.


Regards
Alex Kennedy

Last edited by Stijloor; 4th September 2010 at 02:25 PM.
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