Quality Control Unit-The Science Gatekeeper of CGMP Products
SYANG YANG SU
Suss Technology Inc. 33 Willow Tree Lane, Irvine, CA 92715, U.S.A.
ABSTRACT
The importance of the quality control unit to gatekeep pharmaceutical products to satisfy CGMP regulation is discussed. Scientific results and data are needed in most cases to answer FDA's questions. Laboratory's work functions, i.e. quality control (QC), analytical method development and validation (AM) and stability (STB) have been included. The role of quality assurance (QA) has been discussed briefly. Analytical method validation, stability indicating method development and validation, specification and standard testing method preparations are critical tasks that may affect FDA's approval of the product and decision on whether a quality control unit of a company can ensure the products' good quality. Also mentioned are the "retest","training/qualification" and "calibration of instruments" issues. A discussion is also made on the most recent trend in the US for considering using the first party or the third party to audit or inspect facilities to lessen the FDA's burden on frequent inspection.
Key words: Quality assurance unit, pharmaceutical laboratory, current good manufacturing practice (CGMP), laboratory control, pharmaceuticaldocumentation