PDA TR19_快速鉴别方法调查_Rapid ID Method Survey_1990.pdfVIP

Rapid/Automated ID Methods Survey 快速/自动化识别方法调查 PDA Microbial IDTask Force PDA 微生物识别工作小组 Parenferal DrugAssociation 注射药物委员会 PDA Microbial IDTask Force PDA 微生物识别工作小组 Foryears, pharmaceutical companies have monitored the microflora of sterile production areas in an effort to establish a level of microbial control necessary to produce a quality product. More recently, manufacturing practices have evolved to include monitoring of raw materials and over-the-counter products. Concomitant with the evolution of expanded monitoring programs has been the recognition of the importance of qualitative monitoring of the microflora.The importance of the occurrence of opportunistic pathogens made its impact on the industry in the 1970s. Routine microbial ID has since become an important tool in the identification and elimination of contamination problems within the pharmaceutical industry. 许多年来，制药企业一直监测着微生物无菌生产区，努力建立一个可生产优质产品的微生物控 制水平。最近，生产管理规范已包括原料监测和不需处方即可合法销售的产品。伴随着监测项 目的改革扩大，微生物质量监测的重要性被认可。病原菌的发现对20世纪70年代的工业产生 相当大的影响。常规生物鉴定从此成为制药行业内对污染问题进行验证和消除的一个重要工具。 Although the GMP regulations require a microbial control program, they are vague and generalwhen it comestothesubject of identification. 虽然CMP规程要求微生物控制计划，但 当它涉及到鉴别时，它们就比较模糊和笼统。 Code of Federal Regulations 211.113: Appropriate written procedures designed to prevent microbial contamination of drug products purporting to be sterile shall be established and followed. 为防止微生物污 染，应建立并遵循适当的书面程序使药物无菌。 The LVPGMPs proposed in 1976 made a reference to microbial ID: 1976 年提议的低压防护 GMP涉及到微生物识别： Representative colonies of microorganisms found by monitoring required in this section shall be identified by genus. 被这部分所需的监测器发现的微生物典型菌落 可用基因识别。 The current FDA Guideline on Aseptic Processing makes reference to the need for microbial identification with several issues. These include sterility test failure investigations, characterizations of environmental isolates