INVESTIGATION OF MICROBIOLOGICAL DATA （对微生物的调查数据）.pdfVIP

INVESTIGATION OF MICROBIOLOGICAL DATA DEVIATIONS INTRODUCTION It is difficult to discuss the current climate ofproceduralizcd investigations without some mention of the 1993 Barr Decision (Madsen, 1994). Barr Laboratories had a history of repeated current good manufacturing prdctice (cOMP) deficiencies, including repealed retesting and resampling of product as well as reprocessing of defective product without adequate justification in a practice that has come to be known as testing to compliance. This is nol good practice - the out-of- specification (OOS) data is telling the manufacturer important information about the product and must be resolved. Unfortunately for the microbiology community, this initial situation, as well as most of the subsequent writing on this topic, has focused on 005 from an analytical chemistry perspectivc, The Food and Drug Administration (FDA) has provided guidance following the Barr decision, and drafted thc Guidance for Industry - Investigating Out of Specification (005) Test Results for Pharmaceutical Production (FDA, 1998) which was rewriuen and re-releascd in 2006, Interestingly, this guidance document only brieny touches upon microbiological data, stating that the USP prefers the use of averages because of the innate variability of the biological test system. In addition, this guidance document specifically excludes microbiology from its scope in footnote 3. 2 Seal( Sutton On the international front. the International Conference on Hannonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has provided some guidance on what is meant by a specification. The guidance directs that Specifications arc chosen to conf