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近日，F(xiàn)DA發(fā)布Alvotech HF（安沃泰克）的483缺陷報告，其中提及該公司偏差、OOS/OOE管理混亂的缺陷，如下：

該公司將OOS/ OOE事件及相關(guān)生產(chǎn)調(diào)查納入同一份實驗室調(diào)查記錄進(jìn)行管理，對于經(jīng)實驗室調(diào)查確認(rèn)的無法解釋的偏離規(guī)格、接受標(biāo)準(zhǔn)或其他符合性標(biāo)準(zhǔn)的情況，不再啟動偏差調(diào)查。與實驗室調(diào)查相關(guān)的生產(chǎn)調(diào)查未包含在偏差趨勢分析中。

該公司 SOP允許經(jīng)質(zhì)量部門評估和書面論證后，可取消已發(fā)起的偏差。自 2023年4月1日起，47項偏差被取消。包括：

基于對產(chǎn)品和工藝無影響且屬于 “一次性事件…… 在生產(chǎn)中已立即糾正”，偏差未經(jīng)進(jìn)一步調(diào)查和 CAPA實施即被取消。

多個在B級潔凈區(qū)檢出假單胞菌的偏差均被取消。

該公司的 SOP允許將偏離 GMP/GDP 的輕微情況作為質(zhì)量事件進(jìn)行管理。此類事件因其根本原因被認(rèn)為是顯而易見，并非總是會得到全面調(diào)查和補(bǔ)救。例如，

17 起涉及未在規(guī)定時間內(nèi)審核各類日志的質(zhì)量事件和問題。

多起與數(shù)據(jù)完整性和文件控制相關(guān)的質(zhì)量事件（例如，操作人員使用 “計算器” 登錄、QA發(fā)放的受控文件缺少規(guī)定的頁眉和頁腳），由 QA 在未進(jìn)行進(jìn)一步調(diào)查的情況下關(guān)閉。

多起質(zhì)量事件在 QA 要求進(jìn)一步調(diào)查的情況下仍被關(guān)閉

生產(chǎn)過程中某檢測器探頭信號線缺失而使用了不同的信號線。該事件在未進(jìn)行調(diào)查的情況下被關(guān)閉，而通過臨時變更管理。

缺陷翻譯如下：

Written records of unexplained discrepancies or the failure of a batch or any of its components to meet specification, do not always contain a thorough investigation, or appropriate documentation, conclusions, and follow-up.

無法解釋的差異或批次或其任何組件不符合標(biāo)準(zhǔn)的書面記錄，并不總是包含徹底的調(diào)查或適當(dāng)?shù)奈募⒔Y(jié)論和后續(xù)行動。

Specifically:

具體情況：

A. You implemented a QMS update for management of OOS/OOE events and associated manufacturing investigations under one laboratory investigation (LI-xxxx) record on 10 Jul 2024. As a result, in deviation from your SOP-0922 v.18, deviation records (DEV-xxxx) are no longer opened for unexplained departures from specification, acceptance criteria or other conformance standards confirmed by your initial laboratory investigation. Manufacturing investigations associated with laboratory investigations were not included in your (b)(4) deviation trending.

A. 貴公司于 2024 年 7 月 10 日進(jìn)行了質(zhì)量管理體系（QMS）更新，將OOS/ OOE事件及相關(guān)生產(chǎn)調(diào)查納入同一份實驗室調(diào)查（LI-xxxx）記錄進(jìn)行管理。因此，與貴公司 SOP-0922 第 18 版不符的是，對于經(jīng)初始實驗室調(diào)查確認(rèn)的無法解釋的偏離規(guī)格、接受標(biāo)準(zhǔn)或其他符合性標(biāo)準(zhǔn)的情況，不再啟動偏差記錄（DEV-xxxx）。與實驗室調(diào)查相關(guān)的生產(chǎn)調(diào)查未包含在貴公司的偏差趨勢分析中。

B. Your SOP-0922 v. 18 provides for cancellation of deviations, with assessment and documentation of justification by your Quality Unit (QU). From 01 Apr 2023 (47) deviations were cancelled. For example:

B. 貴公司 SOP-0922 v. 18規(guī)定，經(jīng)質(zhì)量部門（QU）評估和書面論證后，可取消偏差。自 2023 年 4 月 1 日起，47項偏差被取消。例如：

i. DEV-3197 opened 10 Aug 2023 for failure of installation during manufacture of batch (due to incorrect (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) was cancelled without further investigation and CAPA implementation based on lack of product and process impact and due to being a “one time event… corrected immediately in the same batch”.

i. DEV-3197 于 2023 年 8 月 10 日發(fā)起，原因為某批次生產(chǎn)過程中安裝失敗，基于對產(chǎn)品和工藝無影響且屬于 “一次性事件…… 在該批次中已立即糾正”，該偏差未經(jīng)進(jìn)一步調(diào)查和 CAPA實施即被取消。

ii. DEV-4246 opened 11 Oct 2024 for (b)(4) CFU of suspected Bacillus spp. recovered in Grade B (b)(4) air monitoring, DEV-4308 opened 05 Nov 2024 for (b)(4) CFU of suspected Bacillus spp. recovered from personnel monitoring, DEV-4754 opened 22 Apr 2025 for (b)(4) CFU of suspected Bacillus spp. in Grade B (b) (air monitoring). In all cases another objectionable organism Pseudomonas spp., was identified and these deviations were cancelled.

ii. DEV-4246 于 2024 年 10 月 11 日發(fā)起，原因是 B 級 (b)(4) 空氣監(jiān)測中檢出 (b)(4) CFU疑似芽孢桿菌屬的微生物；DEV-4308 于 2024 年 11 月 5 日發(fā)起，原因是人員監(jiān)測中檢出 (b)(4) CFU 疑似芽孢桿菌屬的微生物；DEV-4754 于 2025 年 4 月 22 日發(fā)起，原因是 B 級 (b) 空氣監(jiān)測中檢出 (b)(4) CFU 疑似芽孢桿菌屬的微生物。在所有案例中，均鑒定出另一種令人關(guān)注的微生物假單胞菌屬，這些偏差均被取消。

C. Your SOP-0922 v.18 provides for managing minor departures from GMP/GDP as quality incidents (QI-xxxx or EVxxxx-xxx prior to 01 Dec 2024). Such incidents are not always fully investigated and remediated as root cause is deemed obvious. For example,

C. 貴方的 SOP-0922 v.18 規(guī)定將偏離 GMP/GDP 的輕微情況作為質(zhì)量事件進(jìn)行管理。此類事件因其根本原因被認(rèn)為是顯而易見，并非總是會得到全面調(diào)查和補(bǔ)救。例如，

i. From 10 July 2024 you opened 17 quality incidents and events involving failure to review various logbooks within the required timeframe. Although CAPAs were implemented in response to some of these events, they failed to prevent their reoccurrence.

i. 自 2024 年 7 月 10 日起，貴方發(fā)起了 17 起涉及未在規(guī)定時間內(nèi)審核各類日志的質(zhì)量事件和問題。盡管針對其中部分事件實施了CAPA，但這些措施未能阻止事件的再次發(fā)生。

ii. Several quality incidents related to data integrity and document control (e.g., QI-000001 opened on 03 Dec 2024 for operator using “calculator” login, and QI-000088 opened 12 Feb 2025 for QA issuing controlled document without required header and footer) were closed by QA without further investigation.

ii. 多起與數(shù)據(jù)完整性和文件控制相關(guān)的質(zhì)量事件（例如，2024 年 12 月 3 日發(fā)起的 QI-000001，涉及操作人員使用 “計算器” 登錄；2025 年 2 月 12 日發(fā)起的 QI-000088，涉及QA發(fā)放的受控文件缺少規(guī)定的頁眉和頁腳）由 QA 在未進(jìn)行進(jìn)一步調(diào)查的情況下關(guān)閉。

iii. Several quality incidents were closed with QA requirement for further investigation: QI-000064 opened 28 Jan 2025 (remember (b)(4) excursion in (b)(4) room), QI-000071 opened 03 Feb 2025 (deviation from (b)(4) requirements), and QI-000107 opened 21 Feb 2025 (false entry performed in MBR). There is no evidence that a follow-up deviation investigation was performed for any of these quality incidents.

iii. 多起質(zhì)量事件在 QA 要求進(jìn)一步調(diào)查的情況下仍被關(guān)閉：2025 年 1 月 28 日發(fā)起的 QI-000064（涉及 (b)(4) 房間的 (b)(4) 超標(biāo)）、2025 年 2 月 3 日發(fā)起的 QI-000071（偏離 (b)(4) 要求），以及 2025 年 2 月 21 日發(fā)起的 QI-000107（在主批記錄（MBR）中虛假錄入）。沒有證據(jù)表明針對這些質(zhì)量事件中的任何一起開展了后續(xù)偏差調(diào)查。

vi. QI-000106 opened 21 Feb 2025 for use of a different (b)(4) probe communication cable due to the correct cable unavailable. The event required automation changes to prevent alarms from blocking the (b)(4) control. The incident was closed without investigation to be managed under a temporary change initiative.

vi. 2025 年 2 月 21 日發(fā)起的 QI-000106，原因是XX探頭信號線缺失而使用了不同的信號線。該事件需要對自動化程序進(jìn)行更改以防止報警從而干擾 (b)(4) 控制。該事件在未進(jìn)行調(diào)查的情況下被關(guān)閉，而通過臨時變更進(jìn)行管理。

These events represent departures from GMP requirements and therefore do not meet your definition of quality incidents in SOP-0922 v.17 effective at the time of their opening.

這些事件偏離了GMP要求，因此不符合貴方在事件發(fā)起時仍有效的 SOP-0922 v.17 中對質(zhì)量事件的定義。