S.Y. Su


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 PDA'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 PDA's approval of the product and decision on whether a quality control unit of a comapny 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 PDA's burden on frequent inspection.