USP 1116 的新指标 Contamination recovery rate

yc20160802

美国药品生产无菌操作环境监测的重要指南是USP 1116章MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS。
该章适用于需要无菌操作的非最终灭菌药物的环境监测，不适用于口服药和最终灭菌的注射药物。
USP于1991年首次发布发布1116章,2010年对其内容作了重大修订，引用了更科学的微生物监测指标-超标率
（"contamination recovery rates" e.g.,samples that returned microbial counts greater than zero) rather than looking at specific numbers ）。即不再取数个样本里面菌落的平均值作为指标，而是以单个样本作为指标，无论该样本里面的菌落数多少。

例如，在无菌区放置100个沉降碟，其中有一个碟长菌就不达标。这也也是一个更加严格的指标。可能大多数厂家目前难以做到。
FDA今年发出的警告信，首次使用“Contamination recovery rate”这样的词汇：

WARNING LETTER WL 31-17  May 17,2017     Med-Pharmex, Inc.

4. Your firm’s aseptic processing areas are deficient regarding the system for monitoring environmental conditions [21 C.F.R. 211.42(c)(10)(iv)].  Specifically, your firm’s SOP-0024-05-17, Environmental Monitoring Program, Effective March 7, 2016, indicates a “(b)(4)” and set a (b)(4) contamination recovery rate limit for the following categories in the ISO 5 East Fill Room (Room (b)(4)): active air samples, settling plates, contact plates/swabs, and gloves/garments.

A. Your firm does not perform any investigations if the (b)(4) limit is exceeded during a single sampling period, such as one batch, or at one sampling location over the twelve month span.  For example, your firm’s November 2016 trending data showed a (b)(4) recovery rate at equipment surface sample Area (b)(4) (filling nozzle) and a (b)(4) recovery rate at floor surface sample Area(b)(4) (south side of the fill room) but no investigations were conducted for these sites

B. Your firm’s May 2016 trending data did not accurately report an aseptic operator’s personnel bioburden for personnel monitoring samples taken during Media Fill, batch 051616.  The trending data indicated zero counts for the operator with an entry time of 8:50 AM on 05/18/16, while the batch record indicated counts of (b)(4) CFU each on the operator’s (b)(4) and (b)(4).Your firm’s response does not address evaluating trends and investigating individual environmental monitoring excursion on a batch when you exceed the [b4] limit per SOP 0024-05-17 Environmental Monitoring Program, effective date March 7, 2016.

一片红云

学习，谢谢分享！

月光边境

新手围观ing

beiwei5du

还是搞不懂

得过且过

请教一下，根据上面说的1116使用的范围，是不是就不包括口服固体（OSD），盼复

yc20160802

得过且过 发表于 2017-8-17 13:12
请教一下，根据上面说的1116使用的范围，是不是就不包括口服固体（OSD），盼复

不包括口服固体（OSD）

ning_zilv

有没有USP1116的电子版

yc20160802

ning_zilv 发表于 2018-5-4 17:05
有没有USP1116的电子版

附件USP 35-1116 供参考

ysyd

新手围观ing

yyc102

感谢。。。。。。

yyc102

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