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Old 12th July 2006, 10:48 PM
BEVel BEVel is offline
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Please Help! Auditing Pharmaceutical Toll Manufacturers

Before I begin, thank you very much for all the help that the people in the cove has given. although our drive for ISO 9001:2000 has been relegated in the background, there has been an increase in our department's attention to quality! We have conducted our first supplier audits (maintained some and dropped some) and are now going to visit our toll manufacturers to see how our products are made.

Question: Is there a need for us to audit our toll manufacturers for GMP and GLP even though they are already approved by our country's regulating body? (If there is... I wonder how I can objectively do that as that's where I learned everything. )
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Old 16th July 2006, 06:21 PM
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Default Re: Auditing Pharmaceutical Toll Manufacturers

Quote:
Originally Posted by BEVel

Before I begin, thank you very much for all the help that the people in the cove has given. although our drive for ISO 9001:2000 has been relegated in the background, there has been an increase in our department's attention to quality! We have conducted our first supplier audits (maintained some and dropped some) and are now going to visit our toll manufacturers to see how our products are made.

Question: Is there a need for us to audit our toll manufacturers for GMP and GLP even though they are already approved by our country's regulating body? (If there is... I wonder how I can objectively do that as that's where I learned everything. )
There is no requirement to audit suppliers, but there is a requirement to control them. Auditing is one of many possible ways of exercising control.
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