【讨论】PDA TR33评估，验证和实施的替代

清歌一曲月如霜

【讨论】PDA TR33 Evaluation, Validation and Implementation of Alternative and Rapid Micr


On 18 October, the PDA published the long time expected revision of the Technical Report No. 33 "Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods". The report focuses on the use of these methods in pharmaceutical, biotechnological and medical device industries to assure product quality. The report covers methods for testing of sterility, microbial limits, environmental monitoring, water and microbial effectiveness. Furthermore it includes methods for microbial characterization and identification and in-process control.

The technical report addresses staff who is involved in implementation and validation of microbiological test methods. This includes microbiologists and validation specialists in the laboratory as well as suppliers of testing equipment and laboratory managers and supervisors. Amongst these, it will be of interest for those responsible in quality control and regulatory agencies.

The aim of these report is to establish industry-wide criteria on what constitutes an acceptable alternative microbiological method to the compendial method and how to prove it to fulfill expectations of quality organizations as well as regulatory authorities.

The report is structured in 7 chapters covering the following topics:

Introduction
Glossary of Terms
Classical Microbiology and the Move toward Alternative and Rapid Methods
Technology Review
The Validation Process
Implementation: Guidance on Site Commissioning Versus Initial Validation
References


Together with the current revision of the EP chapter about Rapid Microbiological Methods, the TR 33 will be an important step forward to establish modern microbiological methods in the GMP regulated industries.


10月18日，发表了很长一段时间的PDA技术报告第33号“评估，验证和实施替代和快速微生物方法”的修订。该报告着重于使用这些方法在制药，生物技术和医疗设备行业，以确保产品质量。该报告涵盖无菌测试方法，微生物限度，环境监测，水和微生物的有效性。此外，它包括微生物鉴定和识别和过程控制方法。

技术报告涉及员工涉及到谁在微生物检验方法的实施和验证。这包括微生物学家和验证实验室的专家以及供应商的检测设备和实验室管理者和监督者。这当中，这将是在质量控制和监管机构负责人的兴趣。

这些报告的目的是要建立全行业的标准，什么是可接受的替代药典的方法，以及如何证明其履行质量组织的期望，以及监管当局的微生物法。

报告分为7章，涵盖了以下主题：

介绍
术语表
古典微生物和移动向替代和快速方法
技术评论
验证过程
实施：与最初的验证现场调试指导
参考文献


加上目前快速微生物方法的EP章关于修订， TR 33将是迈出的重要一步，在GMP受管制的行业建立现代微生物学方法。

胜利者

期待文件

布克_41

胜利者 发表于 2013-11-18 12:59
期待文件

等29翻译完了，下一个要么就是33，要么就是48.

胜利者

布克_41 发表于 2013-11-18 13:22
等29翻译完了，下一个要么就是33，要么就是48.

先行谢过

一沙一叶

仪器很贵的。

玻璃杯

布克，加油，永远支持你
我们今后也要组建专业翻译团队

334352444

期待

lumang

等待ing..........

布克_41

leigongw 发表于 2013-11-25 14:49
TR29,48 我自己都平常看时已翻译了一部分，能参与你们这个翻译项目吗，实在没很多时间去慢慢看（经管看英 ...

TR48贴子的连接
https://www.ouryao.com/thread-198350-1-1.html