The role of the compendia in CGMP is an unusual one in the US as, unlike virtually all other industrialized nations, the standards-setting and the enforcement branches of pharmaceutical product regulation are split between two different organizations. Recent years have seen an increase in USP informational chapters (those numbering over “1000”) that blur the line between compendial requirements and CGMP for the QC Microbiologist. These chapters include the draft <1113> (Microbial ID) <1116> (Cleanrooms), <1117> (Best Lab Practice), <1223> (Validation of Alternate Methods), and <1227> (Microbial Recovery) among others. This conference will discuss several of the recent and proposed changes in the compendia from this perspective.
This PMF Conference will provide the participants with a "peek behind the curtain." In addition, the small size and intimate nature of these events provide extensive opportunities to meet and talk with the speakers (compendial participants and internationally recognized experts) and the other participants. PMF conferences are characterized by their interactive nature - come and meet others interested in this vital topic. Make your voice heard!
