中文字幕一级黄色A级片|免费特级毛片。性欧美日本|偷拍亚洲欧美1级片|成人黄色中文小说网|A级片视频在线观看|老司机网址在线观看|免费一级无码激情黄所|欧美三级片区精品网站999|日韩av超碰日本青青草成人|一区二区亚洲AV婷婷

近日，F(xiàn)DA發(fā)布了MMC Healthcare Ltd.的警告信，警告信涉及多個缺陷，包括：

 

“工藝驗證”報告中添加了數(shù)據(jù)，倒簽日期，并更換了頁碼。QA經(jīng)理、QC經(jīng)理、研發(fā)經(jīng)理和生產(chǎn)經(jīng)理承認參與了這些活動。另一份“工藝驗證”報告的審核也發(fā)現(xiàn)了批準(zhǔn)蓋章和簽名存在倒簽。該公司在回復(fù)中表示“由于壓力和緊張，相關(guān)人員無意中簽了之前的日期而不是當(dāng)前日期。”，并僅對相關(guān)人員進行了培訓(xùn)了事。對此FDA并不接受。

 

用于溶出度檢測的紫外-可見(UV-Vis)分光光度計的計算機系統(tǒng)缺乏適當(dāng)?shù)目刂苼泶_保數(shù)據(jù)完整性，例如審計追蹤和規(guī)定的用戶訪問級別。該公司在回復(fù)中表示“希望更新UV/Vis [sic]軟件”以符合要求，并提供了新軟件的報價。FDA不接受該答復(fù)并給出了整改的詳細要求。

 

該公司的微生物檢測方法與USP不同，但未能提供確定所使用的分析方法的充分性的方法驗證數(shù)據(jù)。該公司在回復(fù)中表示他們修改了分析方法以符合USP，并對微生物人員進行了再培訓(xùn)。還表示使用修訂后的方法重新檢驗了有效期內(nèi)大多數(shù)批次的xx溶液，全部合格。對此FDA表示該公司沒有使用修訂后的方法重新檢驗所有有效期內(nèi)的產(chǎn)品和批次。

 

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

 

貴公司未能建立一個足夠的質(zhì)量控制部門以具備責(zé)任和權(quán)力批準(zhǔn)或拒絕所有成分、藥品容器、密封部件、中間產(chǎn)品、包裝材料、標(biāo)簽和藥品（21 CFR 211.22(a)）。

 

During the inspection of your facility our Investigator observed that your 2021 (b)(4) Tablets “PROCESS VALIDATION” report had data added, backdated signatures, and replaced pages. Your Quality Assurance Manager, Quality Control Manager, Formulation Research & Development Manager, and Production Manager admitted to participating in these practices.

 

在對你們工廠的檢查中，我們的檢查人員發(fā)現(xiàn)你們2021 xx片劑的“工藝驗證”報告中添加了數(shù)據(jù)，倒簽日期，并更換了頁碼。你們的QA經(jīng)理、QC經(jīng)理、研發(fā)經(jīng)理和生產(chǎn)經(jīng)理承認參與了這些活動。

 

Review of the (b)(4) Capsules (b)(4) mg “PROCESS VALIDATION” report collected during the inspection also found a backdated approval stamp and signatures.

 

對檢查期間收集的xx膠囊xx mg“工藝驗證”報告的審核也發(fā)現(xiàn)了批準(zhǔn)蓋章和簽名存在倒簽。

 

In your response, you state that “due to pressure and tensions the concerned team mentioned the back date instead of current date unintentionally.”Additionally, you provide evidence of training conducted with your validation team to prevent such issues from recurring.

 

在你們回復(fù)中，你們說“由于壓力和緊張，相關(guān)人員無意中簽了之前的日期而不是當(dāng)前日期。”另外，你們提供了對你們的驗證人員進行的培訓(xùn)的證據(jù)，以防止此類問題再次發(fā)生。

 

Your response is inadequate because you fail to fully review the extent of your practice of backdating CGMP documents. You did not provide adequate evidence to demonstrate that you have conducted a comprehensive assessment of all systems and adequately remediated the deficiencies related to your documentation practices. There is also no indication that you have implemented appropriate and effective corrective actions and preventive actions (CAPAs) throughout your drug manufacturing operations to ensure your manufacturing operation is under control and that your quality unit (QU) is adequately exercising its responsibilities.

 

你們的回復(fù)是不充分的，因為你們沒有全面審查你們的CGMP文件倒簽的程度。你們沒有提供足夠的證據(jù)來證明你們已經(jīng)對所有體系進行了全面的評估，并充分糾正了與你們的文件記錄相關(guān)缺陷。也沒有證據(jù)表明你們在整個藥品生產(chǎn)操作中實施了適當(dāng)和有效的糾正措施和預(yù)防措施(CAPA)，以確保你們的生產(chǎn)操作受控以及你們的質(zhì)量部門(QU)充分履行職責(zé)。

 

2. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

 

貴公司未能對計算機或相關(guān)系統(tǒng)實施適當(dāng)?shù)目刂?，以確保只有經(jīng)授權(quán)的人員才能對主生產(chǎn)和控制記錄或其他記錄進行更改(21 CFR 211.68(b))

 

Your ultraviolet-visible (UV-Vis) spectrophotometer computer system lacked appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels. This UV-Vis system was used for release testing of drug product batches.

 

你們的紫外-可見(UV-Vis)分光光度計計算機系統(tǒng)缺乏適當(dāng)?shù)目刂苼泶_保電子檢測數(shù)據(jù)的完整性，例如審計追蹤和規(guī)定的用戶訪問級別。該系統(tǒng)用于藥品批次的溶出度檢測。

 

In your response, you state that you “would like to update the UV/Vis [sic] software” to be compliant and provide a quote for new software.

 

在你們的回復(fù)中，你們表示“希望更新UV/Vis [sic]軟件”以符合要求，并提供了新軟件的報價。

 

Your response is inadequate because it does not provide sufficient details describing:

 

你們的回復(fù)是不充分的，因為它沒有提供足夠的細節(jié)來描述:

 

Timeframe for your corrective action.

 

糾正措施的時間表

 

Security features of your updated UV-Vis computer system.

 

更新后的UV-Vis計算機系統(tǒng)的安全特性。

 

User access levels, access privileges, or authorized users to perform the analyses, collect data, review data, or perform other functions.

 

用戶訪問級別、訪問權(quán)限或執(zhí)行檢測、收集數(shù)據(jù)、查看數(shù)據(jù)或執(zhí)行其他功能的授權(quán)用戶。

 

Integrity of data generated by your computerized systems in the interim and any other interim measures, prior to the full implementation of your corrective actions.

 

在你們?nèi)鎸嵤┘m正措施之前，你們的計算機化系統(tǒng)在過渡期間和任何其他過渡措施中產(chǎn)生的數(shù)據(jù)的完整性。

 

Extent of this practice and how you will fully secure other CGMP computer systems in your facility.

 

這種做法的程度，以及你們將如何完全保護你們工廠其他CGMP計算機系統(tǒng)。

 

3. Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

 

貴公司未能建立分析方法的準(zhǔn)確性、靈敏度、專屬性和可重復(fù)性(21 CFR 211.165(e))。

 

You did not use a United States Pharmacopeia (USP) method to test multiple drug products nor did you show equivalency or superiority for your alternate methods. For example, your E. coli test method for (b)(4) Solution and (b)(4) Tablets drug products only required sub-culturing if turbidity was observed. This differs from the USP method which proceeds with sub-culturing regardless of visual observation of turbidity. Additionally, you could not provide method validation data that established the adequacy of the test methods you use.

 

你們沒有使用美國藥典(USP)方法檢測多個藥品，也沒有展示替代方法的等效性或優(yōu)越性。例如，你們對xx溶液和xx片劑藥品的大腸桿菌檢測方法只有在觀察到（TSB）渾濁時才需要進行傳代培養(yǎng)。這與USP方法不同，后者不管是否渾濁都需要進行傳代培養(yǎng)。另外，你們未能提供確定你們使用的測試方法的充分性的方法驗證數(shù)據(jù)。

 

Test methods must be validated to show they are suitable for their intended use, and equivalent or better than applicable USP compendial methods. The reproducibility of your test methods is essential to determine if your drug products meet established specifications for microbial attributes.

 

分析方法必須經(jīng)過驗證，以表明它們適合其預(yù)期用途，并且相當(dāng)于或優(yōu)于適用的USP藥典方法。分析方法的可重復(fù)性對于確定你們的藥品是否符合既定的微生物屬性標(biāo)準(zhǔn)至關(guān)重要。

 

In your response, you state that you revised your test method to align with the USP and retrained your microbiologists. You also state that you retested most batches of (b)(4) Solution within expiry using the revised method, all of which passed.

 

在你們的回復(fù)中，你們說你們修改了分析方法以符合USP，并對你們的微生物人員進行了再培訓(xùn)。你們還聲明你們使用修訂后的方法重新檢驗了有效期內(nèi)大多數(shù)批次的xx溶液，全部合格。

 

Your response is inadequate. You do not commit to retest all products and batches within expiry with the revised method. In addition, there is no indication that your method is equivalent or superior to the USP. There is also no information to evaluate all your test methods to ensure they are aligned with the USP.

 

你的答復(fù)不充分。你們沒有承諾使用修訂后的方法重新檢驗所有有效期內(nèi)的產(chǎn)品和批次。此外，沒有證據(jù)表明你們的方法等于或優(yōu)于USP。也沒有信息來評估你們所有的分析方法以確保它們與USP一致。