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A GUIDE TO INSPECTION OF  PHARMACEUTICAL QUALITY CONTROL LABORATORIES

The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control and a significant portion of the GNP regulations pertain to the quality control laboratory and product testing.  Additionally, Compliance Program 7346.832 requiring pre-approval NDA/ANDA inspections contains general instructions to conduct product specific NDA/ANDA inspection audits to measure compliance with the applications and GMP requirements.  This includes pharmaceutical laboratories used for in process and finished product testing.

INTRODUCTION

 

There are several basic objectives when conducting an inspection of the laboratory.  These include assuring that test data is authentic and accurate, that there is compliance with laboratory GMP’s and that there is compliance with filed commitments.

 

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