美国FDA对无菌药品生产检查发送警告信的指导

kslam

美国FDA对无菌药品生产检查发送警告信的指导包括10个关键点.

《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"

胜利者

谢谢

4lolololo

什么东东？

小飞侠

谢谢了，关注FDA

小米0

下载学习一下，谢谢楼主分享~

machupicchu

又出问题了，下载多次，都不成功。

hldmfw

谢谢分享   

beiwei5du

谢谢提供相应的资料，但是不知道这个是选取自哪一个版本的7256.002A呢？？？能否贴出原文？？？
现在7356.002a(implementation date:September 11, 2015)增加至了16个关键点。同时其关联的是regulatory and/or administrative action，并不是仅仅针对于警告信，请核实一下，非常感谢。
The following list of deficiencies represents exampl es of practices that CDER believes could warrant regulatory and/or administrative action (please note the  following is not intended to be an inclusive list):  
1.   Contamination with filth, objectionable  microorganis ms, toxic che micals or other drug chemicals; or a reasonable potential for product conta mination, with demonstrated avenues of contamination such as  poor aseptic methods, contact with unclean equip ment, or airborne contamination.
2.   Failure to assure that each batch confor ms to label claims or established specifications, such as NDA, ANDA, USP monographs, and the fir m’s  finished product specifications.  
3.   Distribution of product which does not conform to established specifications.  
4.   Lack of adequate validation of  critical steps in sterilization processes, including sterilization by filtration; sterilization cycles used for drug products; and, for  aseptically processed products, sterilization processes used to sterilize co mponents (for mulation and/or its ingredients, as well as containers and closures), or to sterilize equip ment surfaces that contact sterile product or any elements of the product.  
5.   Lack of adequate validation of  aseptic processing operations (media  fills).  
6.   Failure to appropriately conduct and docu ment investigations of discrepancies and failures of drug products or any of their co mponents to meet specifications, especially inadequate investigations of  sterility test  failures, media  fill failures and repeated or signifi cant environmental or personnel monitoring results that  meet or exceed action levels.  
7.   Facilities and equip m ent which do not prov ide adequate protection  for aseptically processed product while the sterile product or sterile co mponents are exposed to the environ ment. This includes both lack of robustness due to poor design, as well as failure to m aintain equipment as sterile (e.g.,  by providing proper barriers as well as assuring adequate sterilization frequency).  
8.   Failure to assure a robust cleanroom disinfection progra m. This  may include the failure to assure sufficiently detailed cleaning procedures to assure repeatability in c leaning, or failure to demonstrate the suitability and efficacy of the disinfecting agents used for the critical controlled areas and production equip ment.  
9.   Failure of a  WFI system  to deliver water that consistently  meets chemical,  microbiological and endotoxin specifications.  
10.  For aseptic processing, poor e mployee practices that increase the risk of product conta mination.
11.  Failure to provide adequate training to employees who work in critical operations, such as operators on aseptic processing  lines, operators responsible for initiating and checking sterilization cycles and those who perform  the 100% inspection of filled injectable products.  
12.  Failure to perform adequate 100% inspections of injectable products for particulate  matter and other defects.
13.  Failure of batch records to include co mplete information related to the production and control of each batch, including docu mentation that assures environmental and personnel monitoring data and data related to the support systems, and assure quality unit review of these records prior to approval of a lot for distribution and release. For aseptically processed product, batch documentation includes records of purposeful operator interventions into critical (Class 100 / ISO 5) areas of the line. Operator intervention should be  minimized as much as possible to preclude and control conta mination.
14.  Use of test methodology (sterility test, endotox i n test) that is not adequate or validated.  
15.  Lack of an adequate environmental monitoring progra m, that is, one that does not include dynamic  monitoring during all production shifts or has not established appropriate alert and action levels and, in the case of aseptic processing, does not include representative critical surfaces that come in contact  with sterile product, containers and closures.  
16.  Lack of an adequate personnel monitoring program for aseptic processing operations. For example, the program  does not include daily monitoring of operators’ gloves and periodic monitoring of gowns; has not established appropriate li mits or does not require investigations and corrective actions when li mits are exceeded.  

beiwei5du

这里所说的regultory action到底是什么含义呢？？？是包括advisory action, administrative action和judicial action???那么为什么和administrative action存在并列关系呢？（and）