(完整版)pdatr80《制药实验室数据完整性管理体系》(中英文对照版).pdf

PDA TR 80 《制药实验室数据完整性管理体 系》 （中英文对照版） PDA TR 80 《制药实验室数据完整性管理体系》现已全文翻译完毕，大家可以点击文末 “阅读原文 ”链接下 载中英文对照版全文。由于微信篇幅关系，这里只放出微生物实验室数据完整性的内容： 5.0 Data Integrity in the Pharmaceutical Microbiology Laboratory 5.0 微生物实验室的数据完整性 5.1 General Considerations and Risks 一般原则及风险 The approaches used to investigate the occurrence of suspected data integrity issues that h recently occurred in a pharmaceutical microbiology laboratory can be challenging and, in some cases, may be very different than those used to evaluate similar occurrences in an analytical chemistry laboratory, Many microbiological methods are performed manually; subsequently, the recorded results are often based on the visual observations by an individual scientist performing the tests. 制药企业微生物实验室对可疑数据完整性问题的调查方法，越来越成为一个挑战，并且在一些情况下，与 同样发生可疑数据的化学分析实验室的调查方法完全不同。很多微生物测试方法都是手动操作，以及所有 的测试结果都由微生物测试人员人工检查并记录。 Listed below are a few examples of regulatory observations, Warning Letters, or other institutional accounts that note data integrity problems associated with microbiological laboratory records. These are only examples and are not intended to be an all-inclusive list of concerns: 以下是一些官方检查项，警告信，或其他官方检查关于微生物实验室记录数据完整性问题的情况列举，这 些仅是举例并不完全代表所有与微生物实验室数据完整性相关的问题： ●Company failed to record and report reliable and accurate data for the environmental monitoring (EM) results; for example, contamination in Grade A rooms were recorded and reported as having no viable microorganisms present when, in fact, microbial contamination was present. Specifically, the settle agar plates used in these areas were felsely reported as having “ no colonies present ” but were found to contain 16 colony-forming units (CFU), more than could be reasonably overlooked. ●公司未记录和报告真实准确的环境监测结果数据；例如， A 级区实际存在微生物污染但实际记录和报告 为零。特别是 A 级区沉降菌报告为 “无菌落生长 ”，但实际上发现沉降菌结果为 16cfu ，可能会有更多类