11 – Good Control Laboratory Practice

11 – Good Control Laboratory Practice

Building on Chapter 6 and relevant annexes of the EU GMP guide, this monograph describes the facilities, equipment, quality systems, documentation and management arrangements appropriate to the proper operation of quality control laboratories in the pharmaceutical industry.  It includes consideration of validation and the handling of out-of-specification results.  It will be of value to all those involved in the operation or audit of laboratories.  It was published in March 2005.

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