APIC正在修订ICH Q7 如何实施指南

GMP News
03/08/2016

APIC is working on an enhanced ICH Q7 How to do Guide

APIC正在修订ICH Q7 如何实施指南

The first edition of the "How to do Document - Interpretation of the ICH Q7 Guide" was published by APIC shortly after theICH Q7 Guideline appeared as Step 4 document in November 2000. In the meantime it has undergone a numer of revisions and the current version of the How to do Document to be found on the publications section of APIC's website is an update from August 2015 (version 8). This document was written by experts from the European Industry (CEFIC APIC) and is essentially an interpretation of “how to” implement the requirements of the ICH Q7 Guide based on practical experience.

第一版如何实施ICH Q7指南是APIC在ICH Q7指南于2000年11月达成第4步之后不久公布的。同时，它也经过了大量修订，现行的如何实施文件是2015年8月更新的版本（第8版）。此文件是由欧洲行业专家所写的（CEFIC APIC），主要是根据实际经验解释如何实施ICH Q7指南的要求。

On the occasion of the publication of theICH Q7 Questions & Answers Document in June 2015 another revision of APIC's How to do Document was necessary. APIC is currently working on this new revision (version 9) taking into account the new ICH Q7 Q&A Document which will be incorporated into the How to do Document as a new chapter 21. In this chapter each Question/Answer of the Q&A document is examined and commented with respect to its practical implementation. The following example illustrates what these practical comments look like:

新的ICH Q7问答文件于2015年6月公布后，另一版APIC如何实施文件成为必需。APIC现在正在做准备新版本修订（第9版），其中考虑了新的ICH Q7问答，将其结合至如何实施文件中作为新的第21章。在此章节中，每个问答均被检查并评价其实际实施。以下例子说明了这些实际操作建议看起来的样子：

ICH Q7 Q&A – Question ICH Q7问答---问题
For dedicated equipment, is ‘visually clean’ acceptable for verification of cleaning effectiveness, (i.e., no expectation for specific analytical determination)?
对于专用设备，“目视清洁”是否可以接受作为清洁有效性的核查标准（即，不需要具体的分析检测）？
ICH Q7 Q&A – Answer ICH Q7问答---答
‘Visually clean’ may be acceptable for dedicated equipment based on the ability to visually inspect and sufficient supporting data from cleaning studies (e.g., analytical determination to demonstrate cleaning effectiveness) [ICH Q7, Section 12.76]. Equipment should be cleaned at appropriate intervals (e.g., time or number of batches) to prevent build-up and carryover of contaminants (e.g., degradants or objectionable levels of microorganisms) so that they do not adversely alter the quality of the API [ICH Q7, Sections 5.23, 12.7].

“目视清洁”对于专用设备来说，基于目视检查的能力，和清洁研究中获得的充分的支持性数据（例如，分析检验证明清洁有效性）是可以接受的【ICH Q7，第12.76】。设备应该按适当的时间间隔进行清洁（例如，时间或批次数），以防止污染物的累积和带入（例如，降解物或微生物不能接受的水平），这样他们不会对原料药质量产生不良影响【ICH Q7，第5.23，12.7部分】。

Comment in APIC's How to do Document APIC的如何实施文件里的建议
"dedicated equipment" can be defined in various ways such as:
“专用”设备可以以不同方式来定义，如：

-       a reactor that is used solely for 1 API process

-       一个原料药工厂单独使用的反应釜

-       a reactor used for different intermediate steps of the same API.

-       用于相同原料药不同中间体步骤的反应釜

-       a reactor used for different steps in the same intermediate or API

-       一个用于相同中间体或原料药的不同步骤的反应釜

-       a reactor solely used for 1 stage in 1 process

-       一个只用于一个工艺中同一个步骤的反应釜

Whatever definition is used it should be documented and justified.

不管使用的哪种定义，应该有文件记录和论证。

When visual inspection is applied following points should be considered:

当使用目视检查时，要考虑以下点：

-       adequate lighting

-       足够的照明

-       fully dried

-       全面干燥

-       difficult to clean spots visually inspectable

-       难以清洁的点是否可以目视检查

-       use of cameras, endoscopy

-       使用照相机，检查内镜

-       limit of detection of visual cleanliness

-       目视清洁的检查限度

-       dirty hold time / clean hold time

-       脏设备能放置的时长/清洁设备能放置的时长

-       Campaign length

-       生产周期时长

While the purpose of the ICH Q7 Q&A Document is to clarify some equivocal issues of the ICH Q7 Guideline the comments of APIC's ICH Q7 Q&A How to do Document intend to give support on an even more practical level. So after its finalisation and publication later this year the API industry will have another very useful document available which facilitates the implementation of the ICH Q7 principles.

ICH Q7问答文件的目的是澄清一些ICH Q7指南里比较含糊不清的问题，APIC的ICH Q7问答如何实施文件中的评论则意在更为实际操作的层次给出支持。这样在今年晚些时候其定稿时和公布时，原料药行业将可以获得另一个非常有用的文件，便于ICH Q7原则的实施。

At the pre-Conference Session to the 19th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients on 22 November 2016 in Barcelona APIC will launch the ICH Q7 Q&A How to do Document as a stand alone document. All participants will receive a copy.

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720167611058989/