IPEC辅料重大变更指南

beiwei5du

The International Pharmaceutical Excipients Council Significant Change Guide for Pharmaceutical Excipients
1.1 Purpose
This document is intended to establish a uniform approach to the evaluation of the significance of changes involving the manufacture and distribution of pharmaceutical excipients. The purpose of the evaluation is to consider the impact of the change on the excipient and to determine whether or not the excipient user and/or regulatory authority should be informed. It is recommended that users and excipient suppliers utilize this guideline as the basis for notification requirements in quality and/or supply agreements.
1.2 Scope
This guide is applicable to all excipients used in the manufacture of pharmaceutical products. Although Good Manufacturing Practice (GMP) principles are a focus of this guide, in some instances guidance is provided covering changes concerning Good Distribution Practice (GDP). The principles set forth here should be applied once it has been determined by the excipient manufacturer that an excipient is intended for use as a component of a drug product. This guide applies to excipients manufactured by either batch processing or continuous processing, and the use of the term batch or lot may refer to either type of processing.
1.5 Layout
This guide is divided into several sections.
The first part provides the background discussion necessary for evaluating a change and determining the need to inform the user and/or regulatory authorities.
A section is included that defines the term Significant Change and this is followed by guidance on determining the risk that a change will be significant. Notification processes to customers and possibly regulatory authorities follows, and the guide concludes with a series of specific changes in which the classification possibilities are examined.
Appendix 1 includes some case studies to show how the significance of change can be determined.
Appendix 2 provides a Decision Tree useful in considering the potential impact of a change on excipient performance.
Appendix 3 lists the History of Revision for this guide.
http://101.247.67.17:9011/ipec-europe.org/c3pr90ntc0td/UPLOADS/IPEC_Significant_Change%20_Final_printing_09Oct2014.pdf

pfz2867

有没有中文翻译

beiwei5du

pfz2867 发表于 2017-8-11 10:07
有没有中文翻译

暂时没有

kc1711422001

Thanks for sharing

预知子

谢谢

小金库

谢谢分享