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标题: 20141126 ECA新闻：USP关于“供应链完整性”新提议 94727201410289574598/ [打印本页]

作者: xiaoxiao 时间: 2014-11-29 08:36 AM
标题: 20141126 ECA新闻：USP关于“供应链完整性”新提议 94727201410289574598/
20141126 ECA新闻：USP关于“供应链完整性”新提议

2014-11-28 22:02:31| 分类： ECA新闻|

GMP News
26/11/2014

New USP Proposals on "Supply Chain Integrity"

USP关于“供应链完整性”新提议

An interesting article of the USP on the future USP chapters for supply chain integrity and security can be found in the Pharmacopoeial Forum 40(2).
4 V Y8 N- g$ e, x% B. H* ]现在在美国药典论坛40（2）上可以找到一份USP关于供应链完整性和安全性的有意思的章节，该章节在将来会收入USP。) V2 \/ B+ w3 U% @$ a5 W
Supply Chain Integrity and Security (SCIS) is defined as a set of procedures and technologies which are used to ensure visibility and traceability of products within the supply chain.
# a# J( `( `5 l1 x供应链完整性和安全性被定义为一系列的程序和技术，用于保证供应链中产品的可见性和可追溯性。/ o- U' O4 a3 D( T' W
This aims to protect end consumers against counterfeit products. The ultimate aim is to detect falsified products and prevent them from entering the supply chain and thus the market.
9 W1 }/ r, f; ^6 h6 D其目的是保护最终消费者不受到伪药的伤害。最终目的是发现假药，防止其进入供应链，防止其进入市场。8 X$ [ T+ v" Z# v+ ~
The risks may include:风险可能包括

Adulteration of the material or product
假原料或假药
Misbranded products containing unlabeled ingredients
标识不正确药品，其中含有未标注的成分
Expired products that are relabeled and sold to end-users
过期药品被重新标签并销售给最终使用者
Materials or products meant for destruction
要销毁的原料或产品
Materials and products that are not effectively recalled
未被有效召回的原料和产品( D8 J2 b' x. x/ i

Among the risks involved in the supply chain security is mainly theft of products during storage and/ or transportation which frequently occurs in the practice.
/ v2 p7 a% f7 O/ A在供应链涉及的风险中，安全是在药品存贮和/或运输实践中经常发生的主要问题。
9 p( r T! n6 p$ ^At the end of this guideline, you can find an appendix listing the definition of various terms like:

在指南的结尾，可以找到附录列出了不同术语的定义，如

Adulteration - storage of a material "under insanitary conditions", non GMP-compliant conditions which may have an influence on the quality of the product.
掺假---“在不卫生的条件下”存贮原料，不符合GMP条件可能对产品质量有影响
Counterfeit Drugs
假药
Diversion - "The unlawful redirection of pharmaceutical products [...] to legal and illegal markets"
非法转售---“将药品以非法方式【……】转移至合法或非法市场
Economically motivated adulteration - Production of fraudulent products with the intention to make an economic gain.
经济利益驱动的制假---有意生产假药来获取经济利益# G9 J2 v7 t$ l3 Q

More information about the new Chapter <1083.4> can be found on the USP website of the Pharmacopeial Forum (PF).

关于第<1083.4>章的更多信息参见USP官网药典论坛。

Source: USP

来源：USP http://zhuyujiao1972.blog.163.com/blog/static/986947272014102810231269/

作者: ericzhang 时间: 2014-11-29 10:37 AM
谢谢分享啊

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