欧盟对印度某企业发布不合规报告:包含6条关键和主要观察项,涉及场地主文件、IT/CS 管理、更衣监测、设备、CCS 及 APS 等多方面缺陷!!
2026年02月03日，EU Gmp发布2026年01月31日给Panacea Biotec Pharma Limited的不合规报告。检查中共发现3项关键缺陷、3项主要缺陷，场地主文件、IT/CS 管理、更衣监测、设备、CCS 及 APS 等多方面缺陷。Part 3 第三部分
| Nature of non-compliance: 不合规的性质Critical observations: 关键观察结果：1. The Site Master File did not indicate the outcome of the listed inspections and audits. The failed inspection, leading to OAI status, conducted by the US FDA in 2023 was not reported. 场地主文件（SMF）未载明所列检查与审计的结果。2023 年由美国 FDA 开展的、导致 OAI 状态的不合格检查未予上报。2. Deficiencies of IT systems and CSs management were identified as: 已识别出信息技术系统（IT 系统）和计算机化系统（CS）管理存在以下缺陷：- the ERP system was not indicated on the lists of computerized systems, and it was not validated, the validation had not yet started at the time of the inspection. The system was commissioned on 05.04.2025. ERP 系统未列入计算机化系统清单，且未经过验证，检查时验证工作尚未启动。该系统于 2025 年 4 月 5 日启用。- backup restoration check was not performed in 2025, although it was SOP requirement. Planner and performed restoration checks in 2026 were presented.尽管标准操作规程（SOP）有要求，但 2025 年未执行备份恢复检查。现场提供了 2026 年恢复检查的计划与执行记录。 - there was no clear requirement to verify the validity of data stored in a system before its decommissioning. 3. The gowning qualification monitoring points did not include the backplane of the body and the lower legs for operators who entered the Grade A with their whole body (back of the head, back, bottom). For operators in Grade A and B, only the five finger dabs were monitored, not the whole fingers. The personal monitoring did not take into consideration the non-routine interventions where – occasionally – an operator or engineer had to enter into Grade A with body parts which were not part of the routine monitoring plan. This is a recurring observation from the US FDA report from 2023. 全身进入 A 级洁净区的操作人员，其更衣确认监测点位未包含躯干背板及小腿部位（头后部、背部、臀部）。对于 A 级和 B 级区域的操作人员，仅监测五指指尖涂抹样，而非整根手指。人员监测未考虑非常规干预场景 —— 即操作人员或工程师偶尔需将常规监测计划以外的身体部位伸入 A 级区的情况。该问题为 2023 年美国 FDA 检查报告中的重复观察项。Major observations: 主要观察结果1. The dryer used for the drying of pre/fine filters of AHUs in OSD, was dirty. Recurring observation. 固体制剂车间空调机组预过滤器 / 精过滤器的烘干设备存在脏污情况。该问题为重复观察项。2. Weaknesses identified in the CCS were the followings: - The opening/closing mechanism of the automatic door leading to the Grade B filling room (type DORMA ED 100/ED 250 and the risks and necessary controls related to its mechanism were not captured.通往 B 级灌装间的自动门（DORMA ED 100/ED 250 型）的开启 / 关闭机构，以及与该机构相关的风险和必要控制措施，均未被纳入记录。 - No Contamination Control Strategy (microbial) was developed for the OSD block (especially for oral liquids and ointments/cremes).未针对固体制剂区域（尤其口服液与软膏 / 乳膏剂）制定（微生物）污染控制策略。 - The CCS failed to capture risks specific to certain materials and items, transferred through DPBs with wet mopping and with or without removal of wrapping. As a consequence, CAPA and monitoring programme were not established for those items. 污染控制策略（CCS）未涵盖通过双层中转袋（DPB）转运、采用湿式擦拭、且带 / 不带去除外包装的特定物料和物品的特有风险。因此，未针对此类物品建立纠正预防措施（CAPA）及监控计划。- Joints of the robotic arm used in C-RABS were not identified as hard to disinfect locations, the VHP cycle validation therefore did not address these joints. C‑RABS 中使用的机械臂关节未被识别为难以消毒的部位，因此 VHP 循环验证未覆盖这些关节。3. The conditions triggering anaerobic aseptic process simulation and the pre-requisites necessary to perform such a simulation were not defined in the APS procedure. Non-inherent (corrective) interventions were required to be performed only annually. Durations and number (count) of corrective interventions were not defined in the APS protocol. Corrective interventions performed with open C-RABS door were defined, however only one of the six types was required to be performed per APS and the duration and count of these interventions was not defined. Visual inspection findings (other than intactness issues) were not reported for the APS batches (e.g. particles, fibers and other contaminations).无菌工艺模拟（APS）规程中未规定触发厌氧无菌工艺模拟的条件，以及开展该模拟所需的前提条件。仅要求每年开展一次非固有（纠正性）干预操作。APS 方案中未明确纠正性干预的时长与次数。虽对 C‑RABS 门开启状态下开展的纠正性干预作出了规定，但每次 APS 仅要求实施六种类型中的一种，且未明确此类干预的时长与次数。APS 批次未报告外观检查结果（完整性问题除外，如微粒、纤维及其他污染）。 |
| Action taken/proposed by the NCA: 国家主管当局（NCA）已采取 / 拟采取的措施： Withdrawal, of current valid GMP certificate No. OGYÉI/496-7/2022, NNGYK/07707-2/2026 吊销现行有效的 GMP 证书，证书编号：OGYÉI/496-7/2022、NNGYK/07707-2/2026All certificates revoked. 所有证书均已撤销。 Recall of batches already released 已放行批次的召回The inspectors did not observe any behaviour or manufacturing process that would pose risk to the quality of products already released. 检查人员未观察到任何可能对已放行产品质量造成风险的操作行为或生产工艺。 Prohibition of supply 禁止供应The NCPHP proposes halting of supplies, except those supplying patients being on treatment with the oncology products. Non-vital supplies are proposed to be halted.国家公共卫生中心（NCPHP）建议暂停供货，但正在使用抗肿瘤药物接受治疗的患者所需药品除外。建议暂停非必需药品的供应。 Suspension of clinical trials 暂停临床试验The NCPHP has no information about clinical trials with IMPs from the site 国家公共卫生中心（NCPHP）未掌握该场地涉及试验用药品（IMPs）的临床试验相关信息。 |
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