请教哪位大师GMP验厂缺失根本原因及措施的回复

xqliu

BCGS 发表于 2017-5-18 15:31
有没有推荐的培训机构呢？

您可以，网上搜一下或先与奥星公司联系一下。

zysx01234

可亲可爱 发表于 2017-5-18 17:29
楼主的企业不象是饮片厂，是国外客户来审计的啊。

感觉管理人员不仅数量太少，而且专业性上存在明显不足；这些文件写的不实用

BCGS

zysx01234 发表于 2017-5-19 08:06
感觉管理人员不仅数量太少，而且专业性上存在明显不足；这些文件写的不实用

我能说我们就3个人吗？哈哈哈

zysx01234

BCGS 发表于 2017-5-19 09:42
我能说我们就3个人吗？哈哈哈

小样

BCGS

Requirement:
QS28: Do documented INSPECTION procedures or instructions exist?
MS1: Does the factory have a documented process to ensure that incoming raw materials, components, and/or sub-assemblies conform to specifications, quality standards and US Safety requirements?
PS15: Do the records indicate that devices are manufactured in accordance with the DMR?
PS20: Is there adequate documentation of the acceptance or rejection of the devices?
PS26: Does each lot meet the acceptance criteria established for the device?  
PS50: Are the Quality Assurance procedures, specifications, acceptance criteria for each device identified?  
PS52: Are the  Device History Records (DHR) complete?
PS56: Are the results of the acceptance testing recorded as part of the DHR for each lot of released devices?
LS2: Are laboratory methods (used to release raw materials or finished goods) qualified or standard for the industry?
Description of Nonconformance:
The factory failed to establish written methods for conducting required inspection, and failed to performed all the inspection as required by specifications.
1) Specifications and acceptance criteria for materials and products are maintained and available for review. However, there is not written inspection methods for conducting some of the inspections. For example, there is not written procedure for perform the heat preservation testing of cold/hot pack. Meanwhile, some of testing methods are not appropriate for performing the testing. For example, the vinyl rings are required to be tested agasint their capacity of weight loading. A force of 500 pounds is clamped down on the products. However, the inner air pressure of the products is not identified. In this case, the weight loading will be different if the inner air pressure is different.
2) The factory maintains written procedures to ensure that incoming materials conform to established specifications, quality standards and US safety requirements: Product Monitor & Measure Control procedure (BC-QP8.2.6-2016, Rev B/0); Incoming Material Inspection Instructions (BC-WI-QM07-2016, Rev B/0) and Inspection & Testing Standards (BC-WI-QM06-2016, Rev B/0). However, the raw materials are not tested against the estbalished specifications. For example, the fabrics are required to be tested against color fading and weight. But there is no record available for review review.
3) The inspection records are maintained and available for review. However, the finished products are not adequately tested against the established specifications. For example, cold/hot packs are required to be tested against their capacity of heat preservation, but the producted are not tested against the requirements. Sponge cushions are required to be tested against the capactity of spring back and density. But the products or materials are not tested agasinst the requirements.
Cause Analysis
Correction and Corrective Action
Corrective Action (Preventive measure that will eliminate the possibility of the Nonconformance occurring again):

BCGS

zysx01234 发表于 2017-5-19 09:56
小样

Requirement:
QS32: Do the descriptions include a list of SOPs that are required to perform the job?
QS33: Have personnel been appropriately trained to GMPs?
Description of Nonconformance:
The factory failed to identify the training needs for all job functions, and failed to perform GMP training to new employees immediately upon hire.
1) Documented Job Descriptions are maintained in the factory (BC-WI-AD001-2016, Rev B/0). However, there is not a list of SOPs or training matrix for identifying training needs for each job function.
2) GMP training is annually conducted to all in-service employees, and the training records and training materials are maintained and available for review. However, new employees are not trained to GMPs immediately upon hire (4 new employees are hired in February,  2017).
Cause Analysis (Facility Completion)：《人力资源控制程序》没有条款明确新进人员入职时必须GMP培训方可上岗，且《年度公司员工培训计划汇总一览表》中，新进人员培训课程遗漏GMP培训。以至造成新进人员上岗前未参加GMP培训。
Correction and Corrective Action (Facility Completion) ：行政部于2017年4月20日，提出对新进人员进行GMP补充培训申请，且于2017年4月21日进行了对新进人员的GMP相关培训，保留培训记录及效果评估。
Corrective Action ：行政部修订《人力资源控制程序》，将新进员工岗前GMP培训纳入程序，确保新进人员上岗前参加GMP培训，相关部门认真执行GMP培训，并落到实处，培训时，必须保留培训记录及培训结果得到评估。
以上为问题点及我们的回复
Why the training needs are not identified? Please address the root cause in depth. And update the corrective actions accordingly.
但审核员需要重新提交
此项如何回复，谢谢

zysx01234

BCGS 发表于 2017-5-19 14:28
Requirement:
QS32: Do the descriptions include a list of SOPs that are required to perform the jo ...

Why the training needs are not identified? Please address the root cause in depth. And update the corrective actions accordingly.这话不懂吗？
培训需求的识别！！！根本原因没有搞清楚，说白了，你这个文件规定是不完善的。

zysx01234

BCGS 发表于 2017-5-19 14:28
Requirement:
QS32: Do the descriptions include a list of SOPs that are required to perform the jo ...

算了，送你个文件，把你的破文件修改掉

zysx01234

BCGS 发表于 2017-5-19 14:28
Requirement:
QS32: Do the descriptions include a list of SOPs that are required to perform the jo ...

算了，送你个文件，把你的破文件修改掉

BCGS

zysx01234 发表于 2017-5-19 15:07
算了，送你个文件，把你的破文件修改掉

多谢大神指教。
另外
RequirementS52: Are there written procedures for Medical Device Reporting?
Description of Nonconformance:The factory failed estalish an effective written procedure with regard to DMR per requirements of 803.
1) A written Adverse Event Monitor and Report Control procedure (BC-QP8.2.3-2016, Rev B/0) is maintained in the factory. However, the procedure only states that a MDR event should be reported to FDA via the requirements of 21 CFR 803 in form of 3500A. There is not a detailed program for MDR. Meanwhile, the written procedure specifies that the event should be reported within 10 working days, which violates the requirements of 803 that a event should be reported within 30 calender days or within 5 working days as required.
Cause Analysis ：现有《不良事件监视和报告控制程序》部分条款内容描素不当，不良事件报告对象没有明确，流程不详细，报告途径不清晰，误将不良事件报告期限规定为10天。
Correction and Corrective Action ：向公司下属各部门发出整改通知，修改明确不良事件报告对象、流程、途径及期限符合FDA要求。
Corrective Action：修改《不良事件监视和报告控制程序》，将不良事件报告对象、流程、途径及期限明确写入程序，特别将不良事件报告期限修改为“FDA要求汇报事件为5个工作日，并马上采取纠正措施，一般事件汇报事件为30个日历日”。相关人员认真遵照执行。
Why the procedure is not established to cover the requirements of 803? Please address the root cause in depth, and update the corrective actions accordingly.
我们确实不了解803的要求，所制作的文件也是从网上摘抄下来的，这个根本原因怎么分析。

zysx01234

BCGS 发表于 2017-5-19 15:37
多谢大神指教。
另外
RequirementS52: Are there written procedures for Medical Device Reporting? ...

你们的医疗器械出口美国吗？？

BCGS

zysx01234 发表于 2017-5-19 15:40
你们的医疗器械出口美国吗？？

是啊。

BCGS

zysx01234 发表于 2017-5-19 15:40
你们的医疗器械出口美国吗？？

我们是一类医疗器械

zysx01234

BCGS 发表于 2017-5-19 15:37
多谢大神指教。
另外
RequirementS52: Are there written procedures for Medical Device Reporting? ...

附件为药品的不良反应报告制度，可能医疗器械不一样，仅供参考

zysx01234

BCGS 发表于 2017-5-19 15:41
我们是一类医疗器械

你自己应该研究下FDA相关规定，如何向他们进行报告

BCGS

zysx01234 发表于 2017-5-19 15:50
附件为药品的不良反应报告制度，可能医疗器械不一样，仅供参考

你的这份是药品的，而且只针对国内的医疗事故报告，不合适，但可以借鉴，非常感谢。

zysx01234

BCGS 发表于 2017-5-19 15:54
你的这份是药品的，而且只针对国内的医疗事故报告，不合适，但可以借鉴，非常感谢。

什么都想吃现成的啊，不可能

BCGS

zysx01234 发表于 2017-5-19 15:52
你自己应该研究下FDA相关规定，如何向他们进行报告

已按FDA要求重新修订了内容，只是他问“为什么没有按照803 的要求制定程序文件？是否了解803的要求？请给出不符合项更深层次的原因”这个不晓得如何回复。

BCGS

zysx01234 发表于 2017-5-19 15:55
什么都想吃现成的啊，不可能

没有这个意思，只是我们一类的确实用不上，不要误会啊。

zysx01234

BCGS 发表于 2017-5-19 15:57
已按FDA要求重新修订了内容，只是他问“为什么没有按照803 的要求制定程序文件？是否了解803的要求？请给 ...

其实你们缺少一个负责法规收集的管理员或叫注册员，法务专员。

当初这个文件谁起草的，起草人水平咋样，有无认真阅读对FDA提到803，这个是根本，另外万一803有内容更新了，你们是否收集并修订你们的文件，这也是一个问题。

所以说你们做事没有做到位，文件写的凑凑数。这个人可以是兼职的，但这样一个文件/程序要有并执行。