FDA警告信：质量体系问题举例

质量体系问题也是FDA警告信中的焦点之一，本章列举了FDA警告信中涉及的一些质量体系问题。“You lacked adequate written procedures for various functions, including, but not limited to:

贵司多领域未制定恰当的书面规程，包括但不限于：Quality Unit responsibilities 质量部门职责Vendor audits 供应商审计Corrective actions and preventive actions  CAPA计划Additionally, you do not always follow the procedures you have. For example, during your inspection, you stated your firm does not perform a historical review and (b)(4) as part of the annual product review. Your procedure “Quality Control - Annual Product Review (QC-021)” requires your firm to perform a (b)(4).”另外，贵司未能始终遵循现有的规程。例如，在检查期间，贵司告诉检查官贵司年度产品回顾中没有进行历史回顾和xx。但在贵司规程《质量控制—年度产品回顾(QC-021)》中，要求进行xx。”

“During the inspection, our investigator observed that your quality unit (QU) lacks adequate oversight for the manufacture of your drug product. For example, your QU failed to ensure that:

在检查期间，检查官发现贵司质量部门对药品生产缺少恰当的监督。例如，质量部未能确保：Appropriate finished product specifications for strength and identity were developed, and that each lot of drug product met all specifications prior to distribution in the U.S. market成品制定的关于规格含量和鉴别的标准是恰当的；以及，在销往美国市场前，每批药品都符合所有的标准要求。Process validation was reviewed and approved by the QU prior to distributing drug products to the U.S. market.在将药品销往美国市场前，质量部对工艺验证进行了审核和批准。Cleaning validation was performed, reviewed, and approved to ensure your firm can prevent the potential of crosscontamination from other drug products manufactured on the same shared  equipment.”清洁验证得到恰当执行并经过审核和批准，从而确保贵司能防止产生产品被共用设备生产的另一个产品交叉污染的可能。”

       文章来源：制药工程论坛

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