灯检确认的疑问

beiwei5du

这个是2015年Dr. Reddy's Laboratories Limited的警告性内容，并且在2017年的检查中也提到相应的灯检确认的问题（图片），请问灯检确认以及defect library具体如何系统进行呢？？？

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473604.htm

3.    Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes. (21 CFR 211.100(a))

Parenteral drugs must be essentially free of particulates. However, during the inspection, we observed that your procedure for qualifying the operators who perform visual inspection is unacceptable because you did not document the creation of inspectors’ qualification kits. The challenge test set vials used to qualify your operators were inadequate because particle size in the kits is not specified. There is thus no way to determine if the kits themselves are sufficient to qualify inspectors under the essentially-free standard. Our investigators also documented that your qualification kits for visual inspectors are created (b)(4) and destroyed after use.

In your March 27, 2015 response, you stated that you will create a protocol for preparing new qualification kits and documenting employees’ qualifications.  Your response is inadequate.  You did not indicate how previously inspected products may have been affected by your substandard visual inspection procedures and qualification kits. You also failed to provide the new protocol. Additionally, you did not provide any details on how you intend to train and qualify operators or measure the effectiveness of the new qualification kits.

In response to this letter, assess the effects of your lack of adequate visual inspection procedures and training on all the quality of all batches inspected by operators who were improperly trained and qualified, and provide a summary of your findings. In your summary, note whether each affected product has been distributed or rejected.  Also describe the actions you have implemented to ensure that the finished parenteral drugs you manufacture are essentially free of particulate matter.  

弹剑桃花源

参见PDA tr43

弹剑桃花源

规范目检人员的操作方式，修订目检Sop 规定所有可能的目检缺陷，分为关键。重大。微小缺陷，建立defect library 要图文并茂，缺陷的位置，类型，大小都要有规范，参见USP1790，还要加上AQL抽样检验。还要起草考核的程序，测试样品，怎么考核都要有Sop

弹剑桃花源

考核方式 无菌药品gmp指南 268页有一个案例，可以参考

beiwei5du

弹剑桃花源 发表于 2017-10-26 15:13
参见PDA tr43

谢谢回复，等会儿仔细看看

弹剑桃花源

beiwei5du 发表于 2017-10-26 15:27
谢谢回复，等会儿仔细看看

我刚刚弄完这个目检的Sop，晚上发参考资料给你

beiwei5du

弹剑桃花源 发表于 2017-10-26 15:32
我刚刚弄完这个目检的Sop，晚上发参考资料给你

好的，谢谢！邮箱397434644@qq.com

不怕开水

同求灯检考核等的SOP，，

雁南飞1234

弹剑桃花源 发表于 2017-10-26 15:32
我刚刚弄完这个目检的Sop，晚上发参考资料给你

能发我一份吗？邮箱：1796363449@qq.com

逗逗

同求78529673@qq.com

1044644761

能发一份SOP和TR43给我么，谢谢！1044644761@qq.com