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 Question:
I am looking for material that can instruct me on how I can better judge a raw material supplier. Question Id:2872
Thomas harris
02-29-2008 12:02PM
User Id: 96139
We currently analyze raw materials that arrive in our facility and analyze our finished products. I would like to know how we can reduce the cost of testing raw materials from a risk management outlook. I am looking for rigorous statistical way of determining if we can eliminate raw material testing.

I would also be interested in determining how we can best judge new raw material suppliers before we purchase their product.

Would your course on GMP Raw Materials Program Risk Management help me make these decisions?

 User Answer
Editor CO
03-03-2008 05:03AM
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Dear Thomas,
Thank you for your interest shown in ComplianceOnline. Please find our Expert's reponse as stated below:
Response:
Yes, it would. I also give a course thru University of Wisconsin that may be helpful. . You should follow ICH Q8 and Q9 for risk management and assessment. The regulations require that you always confirm identity, but if you qualify the supplier and do some testing of the raw material, then you can justify a reduction. Most people do not use rigorous statistical approaches because these are upset every time a process change is made.

Judge a new supplier best by performing an audit; obtaining a sample and subjecting it to intensive testing; and asking them to fill out a survey to provide basic information on quality systems.

Please feel free to contact us for further information.

Warm regards,
Team ComplianceOnline
650.620.3937 / 650.620.3915
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