QC人员将实验室电脑带回家，无法联系，FDA声明：QA有责任确保员工理解并遵守DI原则！

近日，FDA发布了对Unexo Lifesciences, Private Limited的警告信，警告信中披露：在检查期间，唯一一台据称拥有所有CGMP 电子数据的计算机没有备份，因为QC 分析师将计算机带回家，多次尝试后仍无法取得联系。FDA认为这限制了其对检查记录的访问，以评估工厂的 CGMP 符合性状态，并被认定为延迟、限制或拒绝检查。

警告信同时还披露了以下缺陷：

• 检查人员在屋顶上发现批生产记录被撕碎在塑料袋中。在被撕毁的记录中，包含在检查期间声称无法找到而缺失的批记录，还包括一些重复的不完整的批生产记录，其批号和放行日期与已提供给检查人员的批记录相同

• 高级管理层承认提供给检查人员的批记录都是“回顾性准备”的

• 生产区域上方的空调风口被发现不干净，药品暴露在从不干净风口流出的空气中

• QC 经理的计算机被用于审查COA 和测试程序，当提供给检查人员时，所有最近的文件和驱动显然在提交给检查人员之前都已被删除。

• QC 分析师通过其个人手机上的 WhatsApp 从第三方合同实验室收到了 Word 格式的 COA，并且已删除所有收到的 COA

FDA在警告信中声明：贵公司未能提供足够的监督，并确保与贵工厂生产的成品药品质量相关的数据的可靠性。你们的QA部门没有履行其监督和控制工厂所有 CGMP 数据的充分性和可靠性的基本职责。此外，QA 部门有责任确保你们的员工理解并遵守数据完整性原则！

警告信缺陷翻译如下：

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

贵公司的质量控制部门未能履行其责任，确保所生产的药品符合 CGMP，并符合既定的特性、剂量、质量和纯度规范 （21 CFR 211.22）。

Your firm failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at your facility. Your quality assurance (QA) department was not exercising its basic responsibilities for the oversight and control over the adequacy and reliability of all CGMP data at your facility. In addition, your QA department is responsible for ensuring your employees understand and adhere to data integrity principles.

贵公司未能提供足够的监督，并确保与贵工厂生产的成品药品质量相关的数据的可靠性。你们的QA部门没有履行其监督和控制工厂所有 CGMP 数据的充分性和可靠性的基本职责。此外，QA 部门有责任确保你们的员工理解并遵守数据完整性原则。

A. You failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). For example, batch production records were found torn in plastic bags on your rooftop. Among the torn records were missing batch production records that you were not able to locate during the inspection for your drug product, (b)(4) Patch, batches (b)(4) which were intended for the U.S. market. The torn records also included duplicate incomplete batch production records with the same batch numbers and issuance dates as the batch records already provided to the investigators, such as (b)(4) Patch batch (b)(4) and (b)(4) Patch batch (b)(4) also intended for the U.S. market.

你们未能准备批生产和控制记录，包括与生产的每批药品的生产和控制相关的完整信息 （21 CFR 211.188）。例如，在你们的屋顶上发现批生产记录被撕碎在塑料袋中。在被撕毁的记录中，包含在检查期间你们无法找到而缺失的批记录，这些记录本来是针对美国市场的。撕毁的记录还包括重复的不完整批生产记录，其批号和放行日期与已提供给检查人员的批记录相同，例如XXX批次和XXX批次，也用于美国市场。

Your executive management admitted to not having all the batch records for the released drug products and batch production records were “retrospectively prepared” to provide to the investigators.

你们的高级管理层承认没有放行药品的所有批记录，并且批生产记录是“回顾性准备”提供给检查人员的。

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

贵公司未能根据药品的性质对设备和器具进行适当的清洁、维护和/或消毒，以防止出现改变药品安全性、特性、剂量、质量或纯度从而超出官方或其他既定要求的故障或污染 （21 CFR 211.67（a））。

Our investigators observed unclean air conditioner vents above production areas that include the(b)(4) machine in which (b)(4) drug products are exposed to the air flowing from the unclean vents.

我们的检查人员观察到生产区域上方不干净的空调风口，其中包括 （b）（4） 机器，其中 （b）（4） 药品暴露在从不干净风口流出的空气中。

Access to Information During Inspection

检查期间的信息访问

During the inspection, the only computer alleged to have all the electronic CGMP data, which was not backed up, was not available because the QC analyst took the computer home and could not be reached after multiple attempts. Additionally the QC manager’s computer was requested to review COAs and test procedures, however, when the laptop was provided all recent files and drives were apparently deleted before being presented to the investigators. This limited FDA’s access to records for inspection to evaluate the CGMP compliance status of your facility.

在检查期间，唯一一台据称拥有所有CGMP 电子数据的计算机没有备份，因为QC 分析师将计算机带回家，多次尝试后仍无法取得联系。此外，QC 经理的计算机被用于审查COA 和测试程序，然而，当提供笔记本电脑时，所有最近的文件和驱动显然在提交给检查人员之前都已被删除。这限制了FDA 对检查记录的访问，以评估你们工厂的 CGMP 符合性状态。

Additionally, you reported your QC analyst was receiving COAs from your third-party contract laboratory in Word format via WhatsApp on his personal cell phone, and he confirmed to have deleted all the received COAs. You do not have appropriate controls to assure integrity and traceability of your COAs from your third-party contract laboratories.

此外，你们报告说，你们的 QC 分析师通过其个人手机上的 WhatsApp 从你们的第三方合同实验室收到了 Word 格式的 COA，并且他确认已删除所有收到的 COA。你们没有适当的控制措施来确保来自第三方合同实验室的COA 的完整性和可追溯性。

When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance documentCircumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection at https://www.fda.gov/media/86328/download.

当持有人、经营者或代理人延迟、限制或拒绝检查时，根据FD&C法案第501（j）条，这些药物可能被认定为掺假。请参阅 FDA 指南：构成延迟、限制或拒绝药品或器械检查的情况。