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近日，F(xiàn)DA 發(fā)布了Natco Pharma Limited的483缺陷報告，其中提及在線粒子系統(tǒng)的相關(guān)的數(shù)據(jù)完整性缺陷：

檢查人員在粒子監(jiān)測系統(tǒng)軟件中檢索到的11份環(huán)境監(jiān)測報告，發(fā)現(xiàn)電子數(shù)據(jù)與附在生產(chǎn)批記錄上的正式報告副本之間存在差異。

檢查人員將電子報告與批記錄中的超行動限打印報告進(jìn)行比較時，發(fā)現(xiàn)結(jié)果已從超行動限（不合格）改為不超行動限。

該公司管理層承認(rèn)，操作人員將在線粒子數(shù)據(jù)保存在U盤中，然后主管在指定的臺式機(jī)上打印測試報告，F(xiàn)DA表示：這種工作流程使得在數(shù)據(jù)生成點(diǎn)與正式報告之間存在數(shù)據(jù)被篡改的可能，并判定該公司在數(shù)據(jù)完整性方面存在重大缺陷。

在線粒子同一采樣點(diǎn)多個批次多次采樣結(jié)果均不合格，未啟動事件報告或調(diào)查。

該公司操作人員將這些在線粒子不合格結(jié)果的報告打印并附在批記錄中。盡管QA部門對這些打印件進(jìn)行了審核，但并未發(fā)現(xiàn)或處理這一偏差。FDA表示：這表明質(zhì)量監(jiān)督不足。

至少發(fā)現(xiàn)了57起即首次采樣不合格，隨后重新采樣，然后合格的事件。盡管這符合該公司SOP“如采樣點(diǎn)超出限度，且是由于人員移動造成的，則在同一位置重復(fù)采樣。”但是沒有提供文件證明不合格是否確實(shí)是由于人員移動造成的。

超過300 份無菌操作期間的環(huán)境監(jiān)測報告未打印并附在批記錄中。

翻譯如下：

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

無菌區(qū)域在環(huán)境條件監(jiān)測系統(tǒng)方面存在缺陷。

Your firm operates XX non - viable particle monitoring equipment XX used to perform XX generate test data for non - viable (NVP) count used in environmental monitoring and cleanroom and qualification activities in Grade A, Grade B, Grade C, and Grade D areas in support of aseptic manufacturing operations in your Unit XX Aseptic processing used for manufacturing XX mg / ml and XX mg / ml product for the US market.

貴公司使用 XX 非活性粒子監(jiān)測設(shè)備進(jìn)行非活性（NVP）計數(shù)測試，數(shù)據(jù)用于 A 級、B 級、C 級和 D 級區(qū)域的環(huán)境監(jiān)測、潔凈室及確認(rèn)活動，以支持XX 毫克 / 毫升和 XX 毫克 / 毫升產(chǎn)品的無菌生產(chǎn)操作。

During our review, we observed that your quality unit does not review the electronic data generated, stored and archived, only using printout as primary data.

在我們的檢查過程中，我們注意到貴公司質(zhì)量部門未能審核所生成、存儲和歸檔的電子數(shù)據(jù)，僅將打印件作為主數(shù)據(jù)。

During our review of the electronic data for non - viable (NVP) during aseptic operations, it was found to be inadequate.

在我們對無菌操作期間非活性（NVP）電子數(shù)據(jù)的審查中，發(fā)現(xiàn)其存在缺陷。

For example, for eleven (11) final sample report results for XX µm and XX µm particles retrieved from the software (electronic data) for XX discrepancies were observed between the electronic data and the official reported hardcopy final results attached to production batch records.

例如，從軟件（電子數(shù)據(jù)）中檢索到的 11 份關(guān)于 XX µm和 XX µm粒子的最終樣品報告結(jié)果顯示，電子數(shù)據(jù)與附在生產(chǎn)批記錄上的正式報告副本的最終結(jié)果之間存在 XX 差異。

This issue affected XX batches from 11/02/2023 to 04/16/2024:

此問題影響了 2023 年 11 月 2 日至 2024 年 4 月 16 日期間的 XX 批產(chǎn)品：

(Injection XX mg/vial, non - US commercial batch).

（注射劑 XX 毫克 / 瓶，非美國商業(yè)批次）。

Upon comparison of the electronic data reports (soft copy) to the printed over action limit data reports in the batch records (hard copy), it was observed that results had been altered from over the action limit (non - conforming) to below the action limit.

在將電子數(shù)據(jù)報告（軟拷貝）與批記錄中的超行動限打印數(shù)據(jù)報告（硬拷貝）進(jìn)行比較時，發(fā)現(xiàn)結(jié)果已從超行動限（不合格）改為不超行動限。

The firm's management acknowledged that prior to July 2024, operators saved data on USB drives and supervisors printed test reports on their assigned desktops, a practice since discontinued. This workflow appears to have allowed for potential manipulation of data between the point of generation and official reporting, representing a significant gap in your firm's data integrity.

貴公司管理層承認(rèn)，在 2024 年 7月之前，操作人員將數(shù)據(jù)保存在 U盤中，然后主管在指定的臺式機(jī)上打印測試報告，這一做法此后已停止。這種工作流程似乎使得在數(shù)據(jù)生成點(diǎn)與正式報告之間存在數(shù)據(jù)被篡改的可能，這表明貴公司在數(shù)據(jù)完整性方面存在重大缺陷。

B. For XX batches

B. 對于 XX 批次

For the injection from 04/16/2024 to 06/06/2025, your firm failed to follow your own standard operating procedure (SOP No. VPD/137 - 12, "Procedure for Operation and Monitoring of Non - Viable Particle Count by XX" effective 02/17/2025) for handling out - of - limit NVP results. The SOP stipulates that if a sampling location fails to be within the limit, an incident report should be initiated with performing an investigation. However, for all XX batches, the same locations were sampled multiple times with failing results until a passing result was eventually obtained, without initiating the required incident reports or investigations. Furthermore, operators printed all data reports, including those with failing results, and attached them to the batch records. Despite Quality Assurance review of these hardcopy printouts, this deviation to the SOP was not identified or addressed. This practice demonstrates a lack of adherence to established procedures and inadequate quality oversight.在 2024 年 4 月 16 日至 2025 年 6 月 6 日的注射劑生產(chǎn)中，貴公司未能遵循企業(yè)標(biāo)準(zhǔn)操作規(guī)程（SOP編號 VPD/137 - 12，“XX非活性粒子計數(shù)操作與監(jiān)測程序”，于 2025 年 2 月 17 日生效）來處理超出限度的非活性粒子（NVP）結(jié)果。該操作規(guī)程規(guī)定，如果采樣點(diǎn)超出限度，應(yīng)啟動事件報告并進(jìn)行調(diào)查。然而，對于所有 XX 批次，相同的采樣點(diǎn)多次采樣結(jié)果均不合格，直到最終獲得合格結(jié)果，期間未啟動所需的事件報告或調(diào)查。此外，操作人員打印了所有數(shù)據(jù)報告，包括那些不合格結(jié)果的報告，并將其附在批記錄中。盡管質(zhì)量保證部門對這些硬拷貝打印件進(jìn)行了審核，但并未發(fā)現(xiàn)或處理這一偏差。這種做法表明缺乏對既定程序的遵守以及質(zhì)量監(jiān)督不足。

C. Additionally, across XX NVP equipment unit

C. 此外，在 XX 非活性粒子設(shè)備單元中

at least 57 different instances were identified where the first sample failed, and the sample was subsequently retested and passed. While this aligns with your SOP's allowance for retesting, the procedure specifically states, 'if a sampling location fails to be within the limit, and the high counts are due to personnel movement, repeat the sampling at the same location.' However, there was no documentation by operators to indicate whether the failures were indeed due to personnel movement, making it impossible to verify if the retesting was justified according to the procedure.

至少發(fā)現(xiàn)了 57 起即首次采樣不合格，隨后重新采樣，然后合格的事件。雖然這符合貴公司操作規(guī)程中對重新采樣的允許規(guī)定，但該程序特別指出，“如果采樣點(diǎn)超出限度，且高計數(shù)是由于人員移動造成的，則在同一位置重復(fù)采樣。” 然而，操作人員沒有提供文件證明不合格是否確實(shí)是由于人員移動造成的，因此無法根據(jù)程序確認(rèn)新采樣是否合理。

D. Finally, your operators failed to print and attach to batch records environmental monitoring data during aseptic operations that appeared to be within specification, resulting in the omission ofrelevant data from batch documentation and preventing proper review by the Quality Unit. Additionally, your firm failed to properly document and review environmental monitoring activities in the change room. Despite a procedure requiring monitoring XX to more than 300 data reports were printed out, documented, or reviewed by your production or quality units.

D. 最后，貴公司操作人員未將無菌操作期間的（據(jù)說）合格的環(huán)境監(jiān)測數(shù)據(jù)打印并附在批記錄中，導(dǎo)致批記錄中遺漏了相關(guān)數(shù)據(jù)，且質(zhì)量部門無法進(jìn)行適當(dāng)審核。此外，貴公司未能妥善記錄和審核更衣室的環(huán)境監(jiān)測活動。盡管有程序要求對 XX 進(jìn)行監(jiān)測，但超過 300 份數(shù)據(jù)報告未被貴公司生產(chǎn)部門或質(zhì)量部門打印、記錄或?qū)徍恕?/span>