20150902 ECA新闻：药典各论5.1.2“生物指示剂”修订草案 - 药群论坛

GMP News
02/09/2015

Revised Draft of Pharmeuropa Monograph 5.1.2. Biological Indicators

药典各论5.1.2“生物指示剂”修订草案

On 15 December 2011 the draft of the revised monograph 5.1.2. "biological indicators in the preparation of sterile products" - old title ' biological ' indicators of sterilisation " - was published in the Pharmeuropa 24.1 for comments. The number of comments and objections was so extensive that it was necessary to revise the draft completely. On 23 June 2015 the new version was published again in Pharmaeuropa 27.3 for public comment.

2011年12月15日，各论5.1.2“无菌产品生产中的生物指示剂”—原标题为“灭菌用生物指示剂”----在欧洲药典在线24.1上公布征求意见。建议和反对意见很多，因此有必要对草案进行全面修订。在2015年6月23日，新修订的版本在欧洲药典在线27.3上重新公布征求意见。

The content of the new draft has been adjusted compared to the first draft. The new document's structure is as follows:

新的草案内容相比于第一版草案已进行了调整。新文件结构如下：

1.       Introduction 概述
2.       Biological Indicators for sterilization processes 无菌工艺所用生物指示剂
2.1.    Description of Biological Indicators for terminal sterilization processes 最终灭菌工艺用生物指示剂描述
2.1.1. Inoculated carriers 接种载体
2.1.2. Self contained Biological Indicators 自抑制型生物指示剂
2.1.3. Characterised spore suspensions 定性孢子混悬液
2.1.4. Custom-made Biological Indicators 定制的生物指示剂
2.2.    Quality requirements for Biological Indicators 生物指示剂的质量要求
2.2.1. User requirement specifications (URS) for Biological Indicators 生物指示剂用户需求手册（URS）
2.2.2. Quality control 质量控制
2.2.3. Suitability for purpose 适用性
3.       Biological Indicators for heat sterilisation 热灭菌用生物指示剂
3.1.    Parameter of Biological Indicators for heat sterilisation 热灭菌用生物指示剂的参数
3.1.1. z-value Z值
3.1.2    Establishment of validation cycle 建立验证循环
3.2.    Biological Indicators for moist heat sterilization 湿热灭菌用生物指示剂
3.2.1. Test micro-organisms 微生物测试
3.3.    Biological Indicators for dry heat sterilization 干热灭菌用生物指示剂
3.3.1. Test micro-organisms 微生物测试
4.       Biological Indicators for gas sterilization 气体灭菌用生物指示剂
4.1.    Test micro-organisms 微生物测试
4.1.1    Ethylene oxide sterilization 环氧乙烷灭菌
4.1.2. Other processes 其它工艺
5.          Biological Indicators for ionising radiation sterilization 离子辐射灭菌用生物指示剂
5.1.       Test micro-organisms 微生物测试
6.          Biological Indicators for moist heat sterilization 湿热灭菌用生物指示剂
6.1.       Test micro-organisms 微生物测试
7.          Indicators for depyrogenation processes 除热源工艺用指示剂
7.1.    Characteristics of the indicator 指示剂特性
7.2.    Test procedure  测试程序

Following the main changes / new features compared with the draft from 2011 are summarised:

以下是相比于2011年草案的主要变化/新内容总结：

1. Introduction 概述

Here it is noted that this document does not apply for the use of biological indicators to validate the sterility of pipework and other non-terminal units.

要注意的是该文件并不适用于管道和其它最终灭菌单元用生物指示剂。

2. Biological Indicators for sterilisation processes 灭菌工艺用生物指示剂

In addition to the previously described 3 types of bioindicator preparations - inoculated carriers, bioindicators in ampoules or tubes (self contained BIs), "custom-made biological indicators" - a 4th type "characterised spore suspension" is described. It consists of a defined number of spores prepared from a clearly characterised and suitable maintained strain of a spore forming bacterial species in stable suspension. Further new descriptions include the topics quality requirements for biological indicators, user requirements, quality control and suitability for purpose.

除了之前所述的三种生物指示剂外----接种载体、安瓿或管（自控式BLS）中生物指示剂、“定制的生物指示剂”----还描述了第4种类型“定性孢子混悬液”。它是由指定数量的孢子组成，采用明确定性和适当维护的菌中制备，在稳定的混悬液中形成细菌种类。另外，新的描述包括了生物指示剂的质量要求、用户需求、质量控制和适用性问题。

5. Biological Indicators for ionising radiation sterilization 离子辐射灭菌用生物指示剂

This topic has been removed in the first draft of the monograph. To demonstrate the suitability of the sterilisation cycle generally no BIs are needed. However, their use may be required for the development and validation of ionising radiation sterilisation in specific cases.

本主题已从第一版草案中移除。为了证明灭菌循环的适用性，一般不需要BLS。但是，在一些研发和验证离子辐射灭菌特定情形下可能会需要。

7. Indicators for depyrogenation processes 除热源工艺的指示剂

This chapter now contains a list of characteristics of the lipopolysaccharide preparations.

本章现在包括了一份脂多糖制剂的特性清单。

To get access to the document please use the following link. After the necessary registration, you have access to the new draft "5.1.2. biological indicators and related microbial preparations used in the manufacture of sterile products, and indicators for depyrogenation processes".

The commenting period ends on 30 September 2015.

征求意见截止2015年9月30日。