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CGMP Audit Frequency


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skredsfan

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Posted 02 January 2013 - 12:11 PM

Looking for some suggestions on Internal CGMP Audit Frequencies. Should CGMP Audits be conducted monthly or would quarterly Audits be sufficient? Our facility is about 600,000 sq.ft with around 325 Employees. We're a producer of Food & Beverage Paperboard Packaging.



mgourley

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Posted 02 January 2013 - 12:20 PM

Looking for some suggestions on Internal CGMP Audit Frequencies. Should CGMP Audits be conducted monthly or would quarterly Audits be sufficient? Our facility is about 600,000 sq.ft with around 325 Employees. We're a producer of Food & Beverage Paperboard Packaging.


Several standards require monthly audits.
My suggestion would be to divide the facility into four areas (don't forget the outside grounds) and do one section per week, thus covering the entire facility each month.

Depending on time and manpower, you could certainly do the whole facility once per month, but I have found that breaking it up makes it easier to manage and gives you a more accurate snapshot of the actual condition of the facility.

Marshall

Edited by mgourley, 02 January 2013 - 12:24 PM.


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islandiceiz

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Posted 07 May 2013 - 02:42 AM

several require monthly audits?






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