201506 ICH Q7官方问答（中英对照） - 图文

201506 ICH Q7官方问答

Q7 Implementation Working Group

ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical

Ingredients Questions and Answers

Current version dated 10 June 2015

In order to facilitate the implementation of the Q7 Guidelines,

the ICH Experts have developed a series of Q&As:

Q7 Q&As Document History

ICH Q7指南：原料药GMP指南

问答 2015-6-10

Code Q7 Q&As

History

Approval by the ICH Steering Committee under Step 4

References

These documents are published at www.ich.org. ICH E2E Pharmacovigilance Planning November 2004

ICH Q1A(R2) Stability testing of new drug substance and products February 2003

ICH Q5A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived

from Cell Lines of Human or Animal Origin September 1999

ICH Q5B Quality of biotechnological products: Analysis of the construct in cells used for the productionof r-DNA derived protein products November 2005

Date 10 June 2015

ICH Q5D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products July 1997

ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products March 1999

ICH Q7 Good Manufacturing Practice of APIs November 2000 ICH Q8(R2) Pharmaceutical Development August 2009 Part I: ?Pharmaceutical Development‘ November 2006

Part II: ?Annex to Pharmaceutical Development‘, November 2008

ICH Q9 Quality Risk Management and the ICH Q9 Briefing pack November 2005 ICH Q10 Pharmaceutical Quality Systems June 2008

ICH Q-IWG Training Programme for ICH Q8/Q9/Q10 November 2010

ICH Q11 Development and Manufacturing of Active Pharmaceutical Ingredients May 2012 Legal Notice: This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided.

The document is provided \authors of the original document be liable for any claim, damages or other liability arising from the use of the document.

The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.

Table of Contents

PREFACE ......................................................................................................................................... 1 1. INTRODUCTION - SCOPE ..................................................................................................... 2 2. QUALITY MANAGEMENT ..................................................................................................... 2 3. PERSONNEL ................................................................................................................................ 3 4. BUILDINGS AND FACILITIES – CONTAINMENT ............................................................ 4 5. PROCESS EQUIPMENT – CLEANING ............................................................................... 5 6. DOCUMENTATION AND RECORDS ..................................................................................... 6 7. MATERIALS MANAGEMENT ................................................................................................. 7 8. PRODUCTION AND IN-PROCESS CONTROLS ................................................................ 8 9. PACKAGING AND IDENTIFICATION LABELLING OF APIS AND

INTERMEDIATES ....................................................................................................................... 8 10. STORAGE AND DISTRIBUTION ....................................................................................... 8 11. LABORATORY CONTROLS ............................................................................................... 9 12. VALIDATION ....................................................................................................................... 11 13. CHANGE CONTROL .......................................................................................................... 11 14. REJECTION AND REUSE OF MATERIALS ................................................................ 12 15. COMPLAINTS AND RECALLS ........................................................................................ 12 16. CONTRACT MANUFACTURERS (INCLUDING

LABORATORIES) ...................................................................................................................... 13 17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND

RELABELLERS .......................................................................................................................... 14 18. SPECIFIC GUIDANCE FOR APIS MANUFACTURED BY CELL

CULTURE/FERMENTATION ................................................................................................... 15 19. APIS FOR USE IN CLINICAL TRIALS ............................................................................ 15 20. GLOSSARY ............................................................................................................................ 16 21. ANNEX: Q&AS LINKED TO THE RESPECTIVE SECTIONS OF ICH Q7 ................. 17

PREFACE 前言

Since the ICH Q7 Guidance was finalised, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due to the interpretation of certain sections. This Question and Answer (Q&A) document is intended to respond to those requests. 自从ICH Q7指南定稿，在全球实施中，有不少要求期望对一些内容的不确定性进行澄清。本问答文件就是为了对这些咨询做出回应。

The ICH Q7 document should be read in its entirety regardless of the nature of the manufacturing activities being conducted to fully understand the linkages between certain sections and successfully implement appropriate Good Manufacturing practices (GMPs) at all stages of the Active Pharmaceutical Ingredients (API) supply chain, including distribution. A table is provided as an Annex of this document showing the link between each Q&A and the relevant Sections of ICH Q7 and other ICH Quality guidance.

ICH Q7文件应作为整体阅读，而不管所实施的生产活动的特性如何，以便全面理解各部之间的联系，成功地在所有API供应链所有环节，包括销售中实施适当的GMP。在本文的附录提供了一份表格，显示出各问答与章节之间的关联，以及ICH Q7与其它ICH质量指南之间的关联。

ICH would like to acknowledge the work undertaken by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S contributed to this document by selecting and reviewing relevant Q&As that had been collected from training sessions since the implementation of Q7 and transferred the output of these reviews to the ICH Q7 IWG for consideration and consolidation, as appropriate. Additional questions were developed based on responses from an ICH survey. PIC/S further contributed to the development of the document as an ICH Interested Party.

IICH希望向PIC/S所做的工作致谢。PIC/S选择和审核了自Q7实施以来在培训课程中收集的相关问答，并将其审核的结果转交给ICH Q7专家工作组供其讨论和成文。还有一些问题是在ICH调查中收到的回复。作为ICH利益相关方，PIC/S对本文的制订做出了贡献。 Please note that ICH Q7 should be applied in combination with the principles laid down for development and manufacturing in ICH Q11 (see definition of API starting material; see also ICH Q8(R2) Part II), Quality Risk Management (ICH Q9), and Pharmaceutical Quality Systems (ICH Q10). GMP principles as described in ICH Q7 should be applied regardless which approach is taken in pharmaceutical development and manufacturing.

请注意ICH Q7应与在ICH Q11（参见API起始物料定义，参见ICH Q8(R2)第II部分）、质量风险管理（ICH Q9）和药物质量体系（ICH Q10）中对药物研发和生产所给定的原则结合使用。不管在药物研发和生产中使用的是何种方法，都应该应用在ICH Q7里所述的GMP原则。

ICH Q7 also describes principles of GMPs to be applied in the manufacture of APIs for use in clinical trials (Section 19) and for APIs manufactured by cellculture/fermentation (Section 18). ICH Q7还描述以适用于临床试验用API（第19部分），以及细胞培养/发酵（第18部分）生产的GMP原则。

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