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近期无菌微生物实验室相关FDA 警告信分享

2023-2024近期无菌微生物实验室相关FDA 警告信分享
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MARCS-CMS 668867 — FEBRUARY 14, 2024
Notably, over 4 days of inspection, numerous actionable recoveries were observed in your ISO 5 environments (more than 20 instances). In stark contrast, your firm stated that no such recoveries had occurred in this environment in the prior 2 years. We also observed contamination on ISO 5 EM plates, but later found that your microbiology analysts failed to document those results in lab records. 值得注意的是,在4天的检查中,在您的ISO 5环境中观察到了许多超行动级别的污染(超过20个实例)。与此形成鲜明对比的是,贵公司表示,在过去两年中,在这种环境下没有发生过此类回收。我们还观察到了ISO 5 EM板上的污染,但后来发现您的微生物学分析师未能将这些结果记录在实验室记录中。(数据可靠性问题严重,不实时记录,造假?)
MARCS-CMS 669808 — FEBRUARY 05, 2024
You failed to ensure the integrity of data generated by your Quality Control (QC) microbiology laboratory. Specifically, our investigators observed that numerous microbiological plates supporting (b)(4), USP API production operations were not read and recorded contemporaneously. After investigators found microbiological plates in a waste bin, QC personnel provided conflicting information as to whether results had been read and recorded on laboratory worksheets following established procedures. The following day, your firm interviewed QC personnel about the plates and the investigation confirmed that test results were not contemporaneously documented. The investigation revealed that QC personnel admitted to not having written down the test results and relying on their memory, indicating, “I haven‘t written it yet” and “It’s in my head.”您未能确保QC微生物实验室生成的数据的完整性。具体而言,我们的研究人员观察到,许多支持API生产操作的微生物平板没有实时读取和记录。在调查人员在垃圾桶中发现微生物板后,QC人员提供了相互矛盾的信息,即是否按照既定程序读取了结果并将其记录在实验室工作表上。第二天,贵公司就平板问题采访了QC人员,调查证实,测试结果没有实时记录。调查显示,QC人员承认没有写下测试结果,并依靠他们的记忆,表示“我还没有写”和“它在我的脑海中。”(同样的数据可靠性问题,回答问题也很草率,中间QC人员似乎提供了多次不准确的信息)
MARCS-CMS 660904 — NOVEMBER 17, 2023
Your QU failed to provide adequate oversight for the retention of original CGMP records. For example, our investigator observed a truck loaded with bags of scrap from Unit (b)(4), as well as bags stored at a central scrapyard intended for shredding. The bags of scrap included, but were not limited to, numerous torn pieces of printer weigh slips pertaining to drug product packaging, and a microbiology laboratory sample label with Quality Assurance wet signatures.贵公司QU未能对CGMP原始记录的保留进行充分监督。例如,我们的研究人员观察到一辆卡车上装载着(b)(4)单元的废料袋,以及存放在中央废料场用于切碎的袋子。这些废料袋包括但不限于与药品包装有关的许多撕裂的打印机称重单,以及带有QA原始签名的微生物实验室样品标签。
The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about the effectiveness of your operations management and QU in assuring the integrity and accuracy of your CGMP records. CGMP记录的不受控制的销毁,以及您缺乏适当的文件记录做法,都会对您的运营管理和QU在确保CGMP记录完整性和准确性方面的有效性提出质疑。(FDA检察官对废弃物还是情有独钟的,确实也总能发现问题)
MARCS-CMS 657325 — OCTOBER 20, 2023
Your firm lacked adequate sterility testing, for example:
A. You failed to show that your sterility test method was suitable to detect microorganisms in your ophthalmic drug products. 您未能证明您的无菌检测方法适用于检测眼科药品中的微生物。(无菌检查方法适用性问题)
B. You lacked growth promotion tests of the media used for media fills and personnel monitoring.您缺乏用于模拟分装和人员监控的培养基的促生长试验。(这个工厂出现的问题都很基础,一般成熟的工厂不太容易出现此类问题了)
MARCS-CMS 636199 — OCTOBER 16, 2023
Operator movements in the critical areas were not always slow and deliberate.操作员在关键区域的行动并不总是缓慢而谨慎的。
An operator blocked (b)(4) air during various activities, including but not limited to, reaching over the open sterile (b)(4) container multiple times, and tilting the (b)(4) towards his body to visualize its interior while (b)(4) out the sterile (b)(4). 操作者在各种活动期间阻挡空气,包括但不限于多次越过打开的无菌容器,并将无菌容器向身体倾斜来观察其内部。(无菌行为意识,操作不规范)
MARCS-CMS 667414 — SEPTEMBER 20, 2023
Dust and trash underneath work surface/deck in your ISO 5 classified biological safety cabinet. ISO 5级生物安全柜中工作表面/甲板下方的灰尘和垃圾。(清洁)
Rust-like discoloration on a HEPA filter diffuser in the ISO 7 classified anteroom. ISO 7分类的休息室中的高效空气过滤器扩散器出现铁锈状变色。(清洁)
An operator allowed trash to accumulate on the front air intake grille of the ISO 5 classified Biological Safety Cabinet which potentially disrupted airflow patterns and thereby introduced contamination risks.一名操作员允许垃圾堆积在ISO 5级生物安全柜的前进气格栅上,这可能会破坏气流模式,从而带来污染风险。(无菌行为意识)
Your firm failed to use a sporicidal agent as part of your disinfection program on the plexiglass shield inside your (b)(4) ISO 5 classified LAFW.  贵公司未能在ISO 5级别LAFW内的有机玻璃防护罩上使用杀孢子剂作为消毒程序的一部分。(消毒不彻底,进一步需要考虑的就是杀菌效力验证表面是否有该材质?)
MARCS-CMS 658878 — SEPTEMBER 11, 2023
Your laboratory records do not include complete testing data to support the analysis performed. For example, negative controls for sterility testing are not documented at the time of performance. The absence of concurrently performed negative controls during sterility testing does not allow full assessment of the suitability of the testing performed.您的实验室记录不包括支持所执行分析的完整测试数据。例如,无菌检测的阴性对照在执行时没有记录在案。无菌检测期间没有同时进行阴性对照,这不允许对所进行检测的适用性进行全面评估。(阴性对照记录的问题,容易忽视的点,延申考虑其它试验的阴性对照是否都有完整的记录?)
MARCS-CMS 649343 — SEPTEMBER 01, 2023
Failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)]. For example, at the time of the inspection: Your written procedure for cleaning the (b)(4) and cleanroom did not specify the contact time for disinfectants.未能建立足够的系统对房间和设备进行清洁和消毒,以产生无菌条件[21 CFR 211.42(c)(10)(v)]。例如,在检查时:您清洁(b)(4)和洁净室的书面程序没有规定消毒剂的接触时间。(消毒剂的接触时间未规定,规程不完善的问题,应根据消毒效果验证数据来规范接触时间要求)
MARCS-CMS 655666 — JULY 20, 2023
Our investigators observed inadequately controlled laboratory reagents (i.e., inadequate labeling), as well as expired testing materials. The use of uncontrolled and expired testing materials may impact the validity of your testing results used to support the release of your drug products.我们的研究人员观察到实验室试剂控制不充分(即标签不充分),以及过期的检测材料。使用不受控制和过期的检测材料可能会影响用于支持您的药品发布的检测结果的有效性。(实验室老生常谈的问题,标识、效期!)
MARCS-CMS 631303 — JUNE 05, 2023
Your SOP SB-027 titled “Equipment Management and Cleaning” lacks adequate cleaning procedures for the equipment (e.g., incubators) used during aseptic processing operations, including but not limited to, use of a (b)(4) agent, frequency of disinfectants used, and disinfectant contact times. Additionally, this procedure does not address cleaning between batches.您的SOP SB-027标题为“设备管理和清洁”,对无菌处理操作中使用的设备(如培养箱)缺乏足够的清洁程序,包括但不限于(b)(4)试剂的使用、使用消毒剂的频率和消毒剂接触时间。此外,此程序没有提及批次之间的清洁。(实验室恒温箱的清洁消毒也很关键,此外,在进行消毒效果验证时很容易忽略实验室区域设备的材质)
发布于 2024-03-29 14:39:41 © 著作权归作者所有
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