澳大利亚FDA 警告信

十二月的雪

澳大利亚药企2018年警告信

JIAOZHX

ok

syhorchid

了解一下

beiwei5du

基础原始数据还是有必要审核的（特别是QC的supervisor),QA在最终放行时可根据风险进行选择性重点抽查。
3.    Your firm failed to establish an adequate quality control unit with the responsibility and authority to approveor reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, and the authorityto review production records to assure that no errors have occurred, or if errors have occurred, that they have been fully investigated. (21 CFR 211.22(a)).你公司未能建立足够的质量部门，使其具备职责和权力来批准或拒收所有成分、药品容器、密闭器、中间体、包材、标签和药品，以及审核生产记录以确保无错误发生，或如有错误发生已经过充分调查的权力（21 CFR 211.22(a)）。
Your quality unit failed to review high performance liquid chromatography (HPLC) assay data for release and stability of your (b)(4) product.
你们的质量部门未能审核HPLC含量数据用于你们XX产品稳定性放行。
During review of your HPLC’s electronic data, we discovered at least 100 “test” injections. Your analytical procedures and methods do not discuss “test” injections. Your laboratory supervisors did not review these injections prior to submitting the data packages for approval. You informed our investigator that, per procedure, your laboratory supervisors and quality unit only review the chromatograms printed and submitted to them by the analysts. Because your analysts did not print the chromatographic results of “test” injections, neither laboratory supervisors nor your quality unit reviewed these injections. Your procedure did not require review of the underlying electronic recordsor data by either laboratory supervisors or the quality unit to ensure their accuracy or completeness. Accordingly, your quality unit relied on incomplete data for batch disposition decisions. Your quality unit failed to ensure the adequacy of procedures for assessing the quality of your drug products.
在审核你们的HPLC电子数据时，我们发现至少有100个“试针”进样。你们的分析程序和方法并未讨论“试针”进样。你们化验室主管并未在提交数据包批准之前审核这些进样。你们告知我们调查人员说依据程序，你们的化验室主管和质量部门仅审核了化验员打印出来并呈交给他们的色谱图。因为你们的化验员并未打印出“试针”进样的色谱结果，因此，化验室主管和质量部门均未审核这些进样结果。你们的程序并未要求化验室主管或质量部门对底层电子记录或数据进行审核以确保准确性和完整性。相应地，你们的质量部门依赖于不完整的数据做出批处置决策。你们的质量部门未能确保评估你们药品质量的程序的充分性。
We observed other examples of your quality unit’s failure provide adequate data management and review procedures, including the following:
我们发现你们质量部门未能提供充分数据管理和审核程序的其它例子，包括：

• Your analysts performed manual integration of chromatograms without instructions that describe when manual integration is permitted and how it is to be done.
  
• 你们化验员执行了色谱手动积分，但并无指导书描述何时允许以及如何执行手动积分
  
• You did not have procedures for reviewing audit trails or electronic data for the Fourier-transform infrared spectroscopy or ultraviolet systems.
  
• 你们并无程序规定审核IR或UV系统的审计追踪或电子数据
  
  

小金库

非常感谢分享