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转自GMP办公室
昨夜，FDA挂出对犹太制药公司Yusef制造实验室的警告信，警告信缺陷显示：该公司投诉热线形同虚设，投诉邮箱也爆满。此外，还有人员责任冲突，要求配方相关变更由研发部门批准，实际上质量体系文件并不包含研发部门。
摘译如下：
Our investigator found that your quality unit had not checked your customer complaint hotline since February 17, 2015, a period of more than 15 months. Firm personnel stated the hotline had not been checked, and the voicemail box was most likely full. According to your standard operating procedure (SOP)Written and Oral Complaints, the quality unit is to check your complaint hotline every(b)(4)to(b)(4)days.
我们的检查员发现你们的质量部门自2015年2月17日开始长达15个月从来没有检查过你们的客户投诉热线。公司人员说热线没有被检查，语音信箱好像也满了。根据你们的标准操作规程《书面和口头投诉》，质量部门有义务每xx~XX天检查一次你们的投诉热线。
Discrepancies in documents
文件冲突
Your response included SOP 05-105.00 Master Formulation File Change Control. According to this procedure, your Research & Development Department is responsible for approving changes to drug product formulations. You also provided SOP 00-100.5 Quality Unit which specifies your plant manager, president, and QA manager as members of the quality unit. It is important that your quality unit maintains appropriate independence, is adequately resourced, and is fully empowered to fulfill its accountabilities and responsibilities under CGMP.
你们回复了SOP 05-105.00《主配方文件变更控制》。根据该文件，药品配方相关的变更需要研发部门的批准。但是你们同时也提供了SOP 00-100.5《质量单位》，规定了你们的质量单位的成员是工厂经理、总监和QA经理。你们的质量单位保有适当的独立性、配有充分的资源、并得到充分授权以满足其岗位职责和GMP责任是很重要的。
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发表于 2017-6-8 06:22:03
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学习借鉴，感谢楼主