【FDA警告信】加拿大Les Produits Chimiques B.G.R.

恨我不成钢

近期，FDA发布了关于加拿大Les Produits Chimiques B.G.R.的警告信（Warning Letter WL 320-18-64），FDA于2017年9月25-27日对其生产场所进行了检查，发现其原料药生产存在严重违反CGMP的行为。

检查缺陷如下：

1.      Failure to perform laboratory testing of API to ensure conformance to specifications and to accurately report results on certificates of analysis (COA).未能执行API检测以确保其符合质量标准并在COA上准确报告结果。

Your firm distributed multiple lots of (b)(4) powderUSP API without completing required release testing for identity. Your COA reported that these drugs met all required specifications. We reviewed your firm’s COA and laboratory notebooks for (b)(4) powder USP lot #(b)(4), as well as for multiple lots of this product dating back to at least 2015. The laboratory notebooks lacked the analytical data to support the information on your COA. Your firm confirmed to our investigator that, although your COA states that the identity tests “Passed,” you did not perform the tests. Although you never performed the required testing, you distributed these API lots to the U.S. market with false information on the COA.

你们公司销售了多批次XX的USP级别API粉，但并未完成所需的放行检测中的鉴别。你们的COA报告说这些药品符合所有需要的质量标准。我们审核了你们公司的USP级XX API粉的COA和化验室记录，以及多个早到2015年的该产品多个批次。该化验室笔记本缺乏分析数据来支持你们COA上的信息。你们公司向我们的调查人员确认，虽然你们的COA声称鉴别检测为“通过”，但你们并未执行该检测。尽管你们从未执行所要求的检测，但你们依据COA上这些虚假信息将这些批次API都销往了美国市场。

In your response, you provided the identity test results for lots produced since 2015; you conducted these retrospective analyses only after our inspection identified that you had never performed the tests in the first place. Your response is inadequate. While you tested lots identified during our inspection that were manufactured since 2015, you did not test all distributed lots within expiry. In addition, you did not conduct a thorough review of all release records to determine whether the test results for other drug quality attributes were falsely reported.

在你们的回复中，你们提交了自2015年以来生产的批次的鉴别检测结果，你们只是在我们检查过程发现你们刚开始并未执行过检测后才执行的回顾性检测。你们的回复是不充分的。虽然你们检测在我们检查过程中所识别出的批次，但你们并未检测所有已销售而仍在效期的批次。另外，你们亦未对所有放行记录进行审核以确定是否有其它药物质量属性检测结果被错误报告。

Customers and regulators rely on certificates of analysis for critical information about the quality and source of their ingredients.Unreliable information on a COA compromises supply-chain accountability andquality assurance, and may put consumers at risk.

客户和监管人员依赖于COA获得药品成分的质量和来源关键信息。COA上不可靠的信息使得供应链不可靠，使得质量无法确保，同时亦让消费者置身风险中。

2.      Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.你们质量部门未能履行其确保你们场所生产的API符合CGMP要求的职责。

Your quality unit failed to perform a number of critical functions to ensure that the (b)(4) powder USP API was manufactured according to CGMP. For example, your quality unit failed to ensure that the records it reviewed included complete data derived from all tests conducted to ensure compliance with established specifications and standards prior to the distribution of an API batch. Your quality unit did not document details such as sample weight and preparation for tests such as (b)(4) content, (b)(4),(b)(4) or (b)(4) and(b)(4) content.

你们质量部门未能履行大量关键职责以确保USP规格的XX API粉依CGMP要求生产。例如，你们质量部门未能确保其所审核的记录包括所执行的所有检测生成的完整数据，以确保在API批次销售之前符合既定标准。你们质量部门并未记录详细信息如样品重量和检测用样品制备如XX含量、XX、XX或XX和XX含量。

Your quality unit also failed to ensure that samples intended for stability studies are stored with controlled temperature and humidity. Your firm kept retain and stability samples of (b)(4) USP in a cabinet in the quality control laboratory without monitoring temperature andrelative humidity.

你们的质量部门亦未能确保稳定性测试用样品存贮在受控的温湿度条件下。你们公司在QC化验室一个柜子里保存着XX USP的留样和稳定性样品，但并未监测温湿度。

In addition, your quality unit did not ensure the cleanliness of buildings and facilities used to manufacture API. You lacked sufficient controls to prevent the presence of pests in your packaging material storage area. At least twice, our inspector observed insects and spider webs in and on plastic-wrapped stacked containers used for packaging API.

此外，你们质量部门并未确保API生产所用建筑物和设施的清洁。你们缺乏足够的控制来防止在你们包装材料存贮区域出现昆虫。我们的检查人员至少有2次在塑料缠绕的堆叠API包装用容器内和上面发现昆虫和蜘蛛网。

Your quality unit also did not ensure that your cleaning validation records are accurate and contain appropriate documentation. For example, you did not document rinse times in your study to validate cleaning ofthe (b)(4) you use to manufacture API.

你们质量部门亦未确保你们清洁验证记录是准确的，并包括有适当的文件记录。例如，你们并未在你们的研究中记录淋洗次数以验证你们用于生产API的XX的清洁操作。

一沙一叶

来料不检测；过程不控制

暴走看啥片

2017年的才公布吗

恨我不成钢

暴走看啥片 发表于 2018-8-15 11:14
2017年的才公布吗

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