美国FDA警告信关于"不允许"的微生物(Objectionable Microorganism)

kslam · 发表于 2012-11-27 22:07:50

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本帖最后由 kslam 于 2012-11-27 22:08 编辑

[size=14.399999618530273px]有一美国FDA警告信关于"不允许"的微生物, FDA对制造商要求是什么?

[size=14.399999618530273px]《孙子·谋攻篇》中说：“知己知彼，百战不殆；不知彼而知己，一胜一负"

sccd · 发表于 2012-11-27 22:35:20

谢谢分享

清风化雨 · 发表于 2012-11-28 07:57:37

信息是一种及时雨.

紫苏叶 · 发表于 2012-11-28 11:07:49

知己知彼~学习一下

yihaoli035 · 发表于 2012-11-28 11:56:50

长知识了，谢谢啦

wangdeyi · 发表于 2012-11-28 22:08:42

什么东西学习下谢谢楼主

海子 · 发表于 2012-11-30 00:52:56

下载学习，谢谢楼主·

shixiongjie · 发表于 2012-11-30 20:24:59

了解一下

GmpForEver · 发表于 2012-12-10 17:07:40

翻译成“有害微生物”较好。以下是警告信原文，大家可以研究讨论
1. Your firm failed to establish and follow appropriate written procedures designed to prevent objectionable microorganisms in drug products not required to be sterile [21 C.F.R. § 211.113(a)].
The FDA collected samples of multiple lots of Zee Antiseptic Wipes and tested them. Several antiseptic wipes tested from two lots contained Burkholderia cepecia. The following is a summary of the results:

a. Lot JT1511-1 (manufactured in August, 2011):  B. cepacia,Staphylococcus intermedius, and Staphylococcus sciuri.

b. Lot JT23210 (manufactured in August, 2010): B. cepacia and Burkholderia pseudomallei.

We note that the label for Zee Antiseptic Wipes indicates that their intended use is to “help prevent infection in minor cuts, scrapes and burns.”  The user is instructed to “dab the wound with the wipe” and “cover with a sterile bandage” [emphasis added]. We also note that your firm is not producing this product as sterile, but instead tests it for microbial contamination. It is essential that your firm’s topical antiseptic drugs be produced in a manner that is appropriate in view of their intended use. The presence of organisms such as Burkholderia cepacia in a product intended to be used for wounds is unacceptable.

Please include in your response the source of the contamination, as well as a list of all products that are potentially impacted by the contamination. In addition, please include the in-process and finished product test results for all potentially impacted lots, distributed or undistributed. Include an explanation of the validated test methods that have been used to test your in-date marketed products for microbiological quality. Provide details on how your firm determined the identity of microbes in your non-sterile topical products, including whether only limited indicator organism testing, or routine speciation of bioburden, was performed when testing each batch for absence of objectionable microorganisms.

We are concerned about your firm’s failure to assure appropriate microbial quality of batches shipped to the US, and the insufficient basis for your actions thus far to address the potential patient hazard posed by your manufacturing practices. Provide a risk assessment of all products that have been released to the market and an action plan with a strong scientific rationale that supports your plans regarding all potentially impacted lots, both distributed and undistributed.

kslam · 发表于 2012-12-10 17:31:32

GmpForEver 发表于 2012-12-10 17:07
翻译成“有害微生物”较好。以下是警告信原文，大家可以研究讨论
1. Your firm failed to establish and f ...

FDA选择了这术语"objectionable microorganism" 是鉴于某些微生物如类鼻疽伯克氏菌, 洋葱伯克霍尔德菌只能影响免疫功能低的病人, 而不会对健康的人有害. 因此，FDA不将其命名为"harmful microorganism" “有害微生物”.

jtbbca · 发表于 2012-12-10 17:36:16

英文的也得好好看看，学学

情非得已 · 发表于 2013-1-8 19:34:15

谢谢分享！！！！！！！！！！！！！！

yanzhengren · 发表于 2016-7-27 09:44:08

谢谢分享。

beiwei5du · 发表于 2017-8-5 16:47:08

这个课件推荐一下！Determination of Objectionable Microorganisms

beiwei5du · 发表于 2017-8-5 16:48:13

Bad Bug Book (Second Edition)
Foodborne Pathogenic Microorganisms and Natural Toxins Handbook
https://www.fda.gov/Food/Foodbor ... Book/ucm2006773.htm

beiwei5du · 发表于 2017-8-5 18:14:20

kslam 发表于 2012-12-10 17:31
FDA选择了这术语"objectionable microorganism" 是鉴于某些微生物如类鼻疽伯克氏菌, 洋葱伯克霍尔德菌只 ...

确实这样的说法：
§211.113 Control of microbiological contamination.

(a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.

304. Several comments requested clarification of the term "objectionable microorganisms" as used in 211.113(a) or suggested alternative descriptions of objectionable microorganisms such as harmful or pathogenic and fecal indicator microorganisms. The Commissioner deliberately chose the word "objectionable" as the appropriate modifier for the term "microorganisms" in this paragraph to cover a number of circumstances. Microorganisms could be objectionable by virtue of their total numbers or their detrimental effect on the product or by their potential for causing illness in the persons ingesting them. A definition of the term is not practical in the regulations, however, because the objectionable nature of a microorganism may develop only in relation to the unique circumstances of a particular formulation, a particular ingredient, a particular method of manufacture, or the conditions found at a particular firm. The Commissioner believes that the use of the word "objectionable" in a very broad sense is a more practical means of expressing the kind of control he intends.

beiwei5du · 发表于 2017-8-5 18:15:46

本帖最后由 beiwei5du 于 2017-8-5 18:17 编辑

现在国内，针对于非无菌原料药或制剂，在objectionable microorganisms这方面还比较弱吧！特别需要专门的微生物学家根据具体的产品情况建立适宜的objectionable microorganisms list.

黄家乐 · 发表于 2019-8-1 10:23:53

下载学习，学习，学习！

小金库 · 发表于 2022-8-6 22:11:43

谢谢分享！！！

美国FDA警告信关于"不允许"的微生物(Objectionable Microorganism)

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