质量部人员不足，FDA批评 QA包揽环境监测、检验、偏差调查和 产品放行！

Your firm’s Quality Unit, comprised of a single quality manager and one technician, assumes multiple roles that include duties among personnel involved in quality control activities, thereby compromising the independence and integrity of quality oversight. Specifically, your Quality Unit activities include:

贵公司质量部门仅由1名质量经理和1名技术人员组成，承担多项职责，包含质量控制活动相关人员的工作，损害了质量监督的独立性与完整性。具体而言，贵公司质量部门活动包括：

• Collection of environmental and personnel monitoring samples.

• 环境与人员监测取样

• Reading and interpretation of environmental and personnel monitoring sample results.

• 环境与人员监测样品结果读取与判定

• Initiation and conduct of investigations into deviations, including out-of-specification (OOS) environmental monitoring results.

• 偏差调查发起与执行，包括环境监测结果超标（OOS）

• Review of batch records.

• 批记录审核

• Final release of finished drug products.

• 成品最终放行

For example, Quality & Testing Manager collected, incubated, and performed readings of lot related environmental monitoring samples. On 11/26/25, the Q&T Manager segregated the lot and provided a partial release of the lot SUCC10020251114. On 11/25/25 the Q&T Manager initiated a Quality Related Event (QRE) investigation reporting a microbial recovery in the samples. On 12/29/25 the Q&T Manager signed final review of the investigation.

例如，质量与测试经理采集、培养并读取批次相关环境监测样品结果。2025 年 11 月 26 日，该经理隔离批次并批准 SUCC10020251114 批次部分放行。2025 年 11 月 25 日，该经理发起质量相关事件（QRE）调查，报告样品中检出微生物。2025 年 12 月 29 日，该经理签署调查最终审核意见。

This consolidation of responsibilities within a limited number of personnel creates a significant potential conflicts of interest and precludes independent oversight. The same individuals responsible for generating environmental monitoring data, and subsequently investigating any excursions, also hold the authority to release drug products influenced by that data.

人员有限并集中承担多项职责，存在极大利益冲突风险，且无法实现独立监督。负责生成环境监测数据并开展偏差调查的人员，同时拥有基于该数据放行药品的权限。