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近日，F(xiàn)DA在發(fā)給Adept Medical Ltd.的警告信中提及滅菌用生物指示劑相關(guān)的缺陷：

未建立生物指示劑（BI） 進(jìn)貨檢驗(yàn)和驗(yàn)收程序

丟棄BI 的出廠合格證

未對(duì)收到的 BI 批次執(zhí)行 BI 含菌量確認(rèn)檢測(cè)，以確保菌落數(shù)在運(yùn)輸或存儲(chǔ)過程中沒有變化，F(xiàn)DA認(rèn)為這是一個(gè)關(guān)鍵步驟

該公司辯解稱：他們使用的 BI 符合 ISO 11138-1：2017 和ISO 11138-2：2017， 并且它們?cè)谑褂们耙恢碧幱跓o菌包裝中。FDA則表示：該公司沒有進(jìn)行任何檢測(cè)來確認(rèn)所購買的BI 在使用時(shí)是否確實(shí)存活。

滅菌后 BI測(cè)試報(bào)告中未記錄無菌裝載中使用的BI 的批號(hào)和有效期等關(guān)鍵信息

翻譯如下：

Your firm's current incoming inspection and acceptance procedure for Biological Indicator(b)(4) (BI) is not adequately established. This inadequacy could compromise the sterilization process, potentially affecting the safety and effectiveness of the NeoZoline V ntilation Tubes. Your firm discards the Certificate of Conformance provided by (b)(4) with each BI batch, which was requested by the FDA investigator during the inspection. It appears that your firm failed to retain critical documents such as the reconciliation sheet, production batch record, or (b)(4) Certification of Conformance, which are required under your own WI22 "Production QC and Release Product Register," specifically section 2.3, to demonstrate that the product was successfully sterilized. The inspection revealed that your firm does not perform BI Population verification tests on the received BI batches to ensure that the population has not changed during shipping or storage. This is a critical step is necessary to provide a high degree of assurance that the BIs are viable to support verification that finished product is successfully sterilized through the (b)(4) Sterilization process. Additionally, the inspection revealed that critical information such as the batch number and expiration date of the BI used in the sterile load is not documented on the post-sterilization B1 Test Reports, which are used as part of the finished device acceptance and release process.

貴公司當(dāng)前的生物指示劑（b）（4）（BI） 進(jìn)貨檢驗(yàn)和驗(yàn)收程序尚未充分建立。這種不足可能會(huì)影響滅菌過程，從而可能影響產(chǎn)品的安全性和有效性。貴公司丟棄了（b）（4）為每個(gè) BI 批次提供的合格證書，這是檢查期間FDA 檢查人員需要的。貴公司似乎未能保留關(guān)鍵文件，例如臺(tái)賬、生產(chǎn)批記錄或（b）（4）合格證明，這些是你們自己的文件：WI22《生產(chǎn) QC 和放行產(chǎn)品登記冊(cè)》，特別是第 2.3 節(jié)所要求的用以證明產(chǎn)品已成功滅菌的文件。檢查顯示，貴公司未對(duì)收到的 BI 批次執(zhí)行 BI 含菌量確認(rèn)檢測(cè)，以確保菌落數(shù)在運(yùn)輸或存儲(chǔ)過程中沒有變化。這是一個(gè)關(guān)鍵步驟，對(duì)于 BI 能夠支持確認(rèn)成品通過XX滅菌程序成功滅菌提供保障是必要的。此外，檢查還發(fā)現(xiàn)，滅菌后 BI測(cè)試報(bào)告中未記錄無菌裝載中使用的BI 的批號(hào)和有效期等關(guān)鍵信息，這些報(bào)告用作成品接受和放行流程的一部分。

(b)(4) your firm's response states that there is no risk for the stenle products manufactured at your facility because the BIs that they use conform to ISO 11138-1:2017 and ISO 11138-2:2017, and that they are in their sterile packaging until they are needed. However, the inspection demonstrated that your firm does not do any testing to verify that the BIs purchased for the purpose of demonstrating that terminal sterilization is achieved, are actually viable when they are used. Additionally, the inspection revealed that they do not capture key data such as BI batch number and expiration date, and thus if a BI falsely indicated that a sterilization was successful, there is no mechanism by which your firm can trace the lots of sterile products back to a failed BI.

（b）（4） 貴公司的答復(fù)指出，貴工廠生產(chǎn)的 stenle 產(chǎn)品沒有風(fēng)險(xiǎn)，因?yàn)樗麄兪褂玫?BI 符合 ISO 11138-1：2017 和ISO 11138-2：2017， 并且它們一直處于無菌包裝中一直到使用前。但是，檢查表明，貴公司沒有進(jìn)行任何檢測(cè)來確認(rèn)所購買的用以證明已實(shí)現(xiàn)最終滅菌的BI 在使用時(shí)是否確實(shí)存活。此外，檢查顯示，沒有記錄 BI 批號(hào)和有效期等關(guān)鍵數(shù)據(jù)，因此，如果 BI 錯(cuò)誤地表示滅菌成功，貴公司就沒有機(jī)制可以將無菌產(chǎn)品的批次追溯到失敗的 BI。

Additionally, your firm did not include documentation or evidence of the corrections or corrective actions because they are in progress and have not been completed. Additionally, given the observations described above, your firm has not provided a commitment to conduct a retrospective assessment of all finished devices whose sterilization was verified using Biological Indicator(b)(4) to determine whether sterility was compromised.

此外，貴公司沒能提供糾正措施的文件或證據(jù)，因?yàn)樗鼈冋谶M(jìn)行中且尚未完成。此外，鑒于上述觀察結(jié)果，貴公司尚未承諾對(duì)所有已使用該生物指示劑進(jìn)行滅菌確認(rèn)的成品進(jìn)行回顧性評(píng)估，以確定無菌性是否受到影響。

我國(guó)GMP指南（2023版）

“生物指示劑的常規(guī)性能測(cè)試一般包括含菌量復(fù)核、純度確認(rèn)、形態(tài)鑒定。如果認(rèn)為有必要，可以用表型法或基因法進(jìn)行菌種鑒別(如在異常情況調(diào)查時(shí))。外購的生物指示劑，當(dāng)完全按照廠家的用途、使用說明使用時(shí)，無需進(jìn)行D值測(cè)定，將供應(yīng)商提供的D值數(shù)據(jù)作為該批指示劑的D值?！吨袊?guó)藥典》指導(dǎo)原則9208 生物指示劑耐受性檢查法指導(dǎo)原則 中，有詳細(xì)的生物指示劑菌含量復(fù)核及D值測(cè)定的方法。”

“典型的微生物進(jìn)廠質(zhì)控(復(fù)核測(cè)試)報(bào)告包含以下內(nèi)容。生產(chǎn)商、菌名、批號(hào)、標(biāo)示含菌量、D值、效期、稀釋過程、稀釋倍數(shù)、計(jì)數(shù)結(jié)果、每個(gè)生物指示劑含菌量、是否合格等?？梢詫⑸镏甘緞┑膹S家質(zhì)檢報(bào)告或其復(fù)印件與上述文件一起存放。檢驗(yàn)合格的生物指示劑要經(jīng)過批準(zhǔn)和發(fā)放后才可以使用。領(lǐng)用時(shí)要登記領(lǐng)用人日期、數(shù)量等。”