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[GMP] FDA2018年第一季度483報告匯總篇:數據可靠性

  • 2018-05-17 16:56
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為您整理當季度FDA 483報告和警告信的缺陷項內容,分為:數據可靠性,質量保證體系,質量控制體系,文件管理,培訓管理,生產體系,廠房與設施,驗證體系,計算機系統驗證等分類,方便您閱讀,收藏,分享缺陷項的內容,協助您學習FDA現場檢查的重點!
 
 
序號:1
 
缺陷關鍵詞:數據可靠性,批記錄
 
來源:FDA警告信 
 
發布日期:20180409
 
企業名稱:英國McCallum Manufacturing Ltd.
 
缺陷項描述:
 
Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR211.188).
 
你公司未制訂批生產和檢驗記錄,來記錄所生產的每批藥品的完整生產和檢驗信息(21 CFR 211.188)。
 
Your production and control records did not define and document process parameters to ensure that in-process materials and your finished drug products meet quality requirements. For instance, your batch records did not include information such as identity of the equipment, actual (b)(4)time, temperature, filling and packaging operation steps, and yield percentage specifications.
 
你們的生產和檢測記錄未定義并記錄工藝參數,以確保中間體和成品符合質量要求。例如,你們的批記錄并未包括如設備識別信息、實際XX時長、溫度、灌裝和包裝操作步驟以及收率百分比標準。
 
 
序號:2
 
缺陷項關鍵詞:數據可靠性,檢測數據
 
來源:FDA警告信  
 
發布日期:20180315
 
企業名稱:印度Keshava Organics Pvt. Ltd
 
缺陷項描述:
 
Failure to maintain complete laboratory control records for test methods.
 
未能保存完整的實驗室檢驗方法記錄。
 
In several instances, you failed to maintain complete data for API tested and distributed to the U.S. For example, we found test data sheets with missing sample weights for identity testing, batch/lot numbers for reference standards and reagents, equipment identification, and complete thin layer chromatography data for related compounds.
 
在數個事例中,你們未能保存銷往美國的API的完整檢測數據。例如,我們發現檢驗數據表缺失了鑒別測試中的樣品重量、對照品和試劑的批號、儀器編號,有關物質的完整TLC數據。
 
 
序號:3
 
缺陷關鍵詞:數據可靠性,檢測記錄
 
來源:FDA警告信  
 
發布日期:20180309
 
企業名稱:米尼加Labocont Industrial SRL 20180309
 
缺陷型項描述:
 
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
 
你們公司未能確保實驗室記錄包括為確保符合既定質量標準所必須的所有檢測項的完整數據(21 CFR211.194(a))。
 
Your firm does not ensure that complete data from assay testing of your finished drug products and active pharmaceutical ingredients (API) are maintained and reviewed by your quality unit. For example, our investigator observed that an analyst failed to document absorbance data generated during assay analysis, and only reported calculated results.
 
你公司未能確保制劑產品和API含量的完整檢測數據由你們質量部門進行保存和審核。例如,我們調查人員發現一位分析員未記錄含量分析中生成的吸收數據,僅報告了計算結果。
 
Because you do not document and maintain complete data from your analyses, it is not possible to evaluate whether the method was followed and data is valid, or to substantively investigate sources of deviations and variation in your laboratory. It is essential that all data generated during analysis is maintained and reviewed to determine whether laboratory procedures are followed, and raw materials and drug products conform to established specifications.
 
由于你們并未記錄和保存來自分析的完整數據,因此無法評估是否遵循檢測方法以及數據是否有效,也無法對你們實驗室內的偏差和波動來源進行實質性調查。保存分析中所生成的所有數據并進行審核對確定是否遵循了實驗室室程序,確定原料和藥品是否符合既定質量標準是很重要的。
 
 
序號:4  
 
缺陷關鍵詞:數據可靠性,檢測數據 
 
來源:FDA警告信  
 
發布日期:20180223
 
企業名稱:中國浙江綠島科技 
 
缺陷項描述:
 
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
 
你們公司未能確保實驗室記錄包括為確保符合既定質量標準所必須的所有檢測項的完整數據(21 CFR211.194(a))。
 
Your firm lacks basic laboratory controls to prevent changes to paper and electronic records for your over-the-counter (OTC) drug products. You were not able to provide analytical test data for three batches of (b)(4) spray and one batch of (b)(4).We found that you created certificates of analysis (COA) for these four batches before they were manufactured and tested.
 
你們公司缺乏基本的實驗室控制來防止對OTC藥品紙質和電子記錄進行修改。你們無法提供3批XX噴霧劑和1批XX的分析檢測數據。我們發現你們在這4批藥品生產和檢測之前就編制了它們的COA。
 
When questioned, your firm acknowledged falsifying the analytical test results on the COA you used to support release and distribution of (b)(4) spray and (b)(4) drug products to the United States.
 
在問到你們時,你們公司告知我們你們捏造了用以支持放行和銷售至美國XX噴霧劑和XX藥品的COA上的分析檢測結果。
 
In addition, we found three electronic data files in the electronic recycle bin of the stand-alone HPLC system you used to test finished drug product (b)(4) spray. Because this instrument lacks back-up and audit trail capabilities, we could not determine how frequently test data obtained prior to “official” batch testing was discarded. You were unable to explain why these electronic files were deleted.
 
此外,我們在你們用以檢測成品XX噴霧劑的單機版HPLC系統的電子回收站發現3個電子數據文件。由于此儀器缺乏備份和審計追蹤能力,我們無法確定你們在“正式”批檢測之前棄除了多少次的檢測數據。你們無法解釋為什么要刪除這些電子文件。
 
cGMP-related data must be retained by a laboratory to enable appropriate assessments and decisions by the quality unit regarding batch disposition and to demonstrate ongoing control.
 
實驗室必須保存cGMP相關的數據,供質量部門進行適當的評估和批處理決定并保證其持續受控。
 
 
序號:5
 
缺陷關鍵詞:數據可靠性,偽造實驗室數據
 
來源:FDA警告信  
 
發布日期:20180216
 
企業名稱:印度Alchymars ICM SM Private Limited
 
缺陷項描述:
 
Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards. 
 
沒有實驗室檢測記錄,其中包括為確保你們API符合既定質量標準所實施的所有實驗室測試所生成的完整數據。
 
Our investigator found that your firm was falsifying laboratory data. For example, the number of colony-forming units (CFU) found on (b)(4) plates for (b)(4)water point-of-use tests differed substantially from the number recorded on your (b)(4) water report. For multiple points of use, your analyst reported far fewer CFU than observed on the plate by our investigator. In addition, while you reported absence of growth on a selective media plate used to detect objectionable microorganisms, our investigator observed growth on this plate. This is concerning because you use(b)(4) water to manufacture products, such as (b)(4) API, that are intended for use in sterile injectable dosage forms.
 
我們的調查人員發現你們公司偽造實驗室數據。例如,在XX用水點檢測XX碟上發現的菌落形成單位(CFU)數量與你們的XX水報告上所記錄的數值有顯著差異。有多個使用點,你們分析員所報告的數值都遠低于我們調查人員在你們碟上看到的。另外,雖然你們報告說在一個用于檢出致病菌的選擇性培養基碟上未檢出微生物生長,但我們調查人員卻在該碟上看到了微生物生長。這種情況令人擔憂,因為你們使用XX水用于例如XX原料藥的生產,該原料藥又將用于無菌注射制劑藥品的生產。
 
 
序號:6
 
缺陷關鍵詞:數據可靠性,設備維護記錄
 
來源:FDA警告信 
 
發布日期:20180216
 
企業名稱:印度Alchymars ICM SM Private Limited
 
缺陷項描述:
 
Failure to properly maintain equipment and to keep complete records of major equipment maintenance.
 
未能對設備進行妥善維護,并保存主要設備維護的完整記錄。
 
Our investigator found damaged product-contact surfaces on your multi-product equipment. For example, the man hole gasket of (b)(4)111 was deteriorating and wrapped in peeling tape. A gasket on the (b)(4)102 was also cracked in one area and wrapped in peeling tape.
 
我們調查人員發現你們多產品生產設備與產品接觸的表面受損。例如,XX111的人孔墊圈損壞,包裹在剝落的膠帶中。XX102的墊圈也有一個地方裂開了,也是包裹在剝落的膠帶中。
 
Your SOP/ENG/39-1, Gasket Management for Equipments and Pipelines which are in Direct Contact with the Product, section 4.18, requires you to replace gaskets in critical areas, including gaskets for (b)(4)111 and (b)(4)102, (b)(4).Your firm was unable to provide gasket replacement records for this equipment during the inspection.
 
你們的SOP/ENG/39-1“與產品直接接觸的設備和管道墊圈管理”第4.18部分要求你們對關鍵區域的墊圈進行更換,包括XX111和XX102的墊圈。你們公司在檢查期間未能提供該設備的墊圈更換記錄。
 
Furthermore, the most recent records of your firm checking the condition of the gaskets for (b)(4)102were from January 2017, more than (b)(4) before our inspection.
 
還有,你們公司檢查XX102墊圈情況的最近記錄是從2017年1月開始的,在我們檢查之前XX時長。
 
This is a repeat observation from our February 2015 inspection. We also note that you have found deteriorating gaskets to be the root cause for finished API particle complaints.
 
這是2015年2月我們檢查中發現的重復缺陷。我們也注意到你們已發現了老化的墊圈是成品原料藥顆粒物投訴的根本原因。
 
Your response is inadequate. You stated that the “involved gasket was immediately substituted” but did not evaluate all other gaskets on your manufacturing equipment. You indicated that you will update your procedure to require a supervisor walk-through to assess product contact surfaces, but did not include sufficient detail (e.g. frequency of equipment inspection). You also failed to address the lack of gasket maintenance records.
 
你們的回復是不充分的。你們聲稱“所涉及的墊圈馬上就被替換了”,但并未評估你們生產設備上所有其它墊圈。你們說你們會更新你們的程序,要求主管現場排查以評估產品接觸表面,但并未包括足夠詳細的內容(例如,設備檢查的頻次)。你們也未解決缺少墊圈維護記錄的問題。
 
 
序號:7
 
缺陷關鍵詞:數據可靠性,偽造實驗室檢測數據
 
來源:FDA警告信
 
發布日期:20180202
 
企業名稱:韓國Cosmecca Korea Co., Ltd. 
 
缺陷項描述:
 
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
 
你們公司未能確保實驗室記錄包括為確保符合既定質量標準所必須的所有檢測項的完整數據(21 CFR211.194(a))。
 
Our investigator documented multiple examples of falsifying laboratory records. Your quality control laboratory employee stated that he fabricated laboratory data for untested finished drug products by manipulating electronic laboratory records. For example, he changed the file names for test results of previously tested drugs so that the file names appeared to reflect the results of other lots of product. Your firm used this falsified laboratory data to determine the strength of your OTC (b)(4) drug products. Your response stated that your quality assurance manager instructed laboratory analysts to manipulate, falsify, or fabricate data.
 
我們的調查人員記錄下了多個偽造實驗室記錄的例子。你們的QC實驗室員工說他通過捏造電子實驗記錄為未檢測的藥品偽造實驗室數據。例如,他更改了之前檢測藥品的檢測結果的文件名,這樣該文件名看起來反映的是另一些批次藥品的檢測結果。你們公司使用這些偽造的實驗室數據來決定你們OTC XX藥品的劑量。你們在回復中聲稱說你們的QA經理指示分析員捏造、偽造或虛構數據。
 
 
序號:8
 
缺陷關鍵詞:數據可靠性,計算機化系統,權限控制
 
來源:FDA警告信 
 
發布日期:20180202
 
企業名稱:韓國Cosmecca Korea Co., Ltd. 
 
缺陷項描述:
 
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)).
 
你公司未能對計算機和相關系統執行適當的控制以確保只有經過授權的人員才可以修改主生產和檢測記錄以及其它記錄(21 CFR211.68(b))。
 
Laboratory equipment used to generate analytical data for release purposes lacked restricted access. For example, analysts shared usernames and passwords, and all users had administrator rights that permitted them to delete or modify files in high-performance liquid chromatography and gas chromatography equipment. You had no mechanism to facilitate traceability of the individuals who changed, adjusted, or modified data generated by computerized systems.
 
用于生成放行所需的分析數據的實驗室設備缺乏權限控制。例如,實驗室共用用戶名和密碼,所有用戶都具有管理員權限,均可以刪除或修改HPLC和GC儀器中的文件。你們沒有機制來審計跟蹤何人修改、調整或改動了計算化系統生成的數據。
 
 
序號:9
 
缺陷關鍵詞:數據可靠性
 
來源:FDA警告信 
 
發布日期:20180202
 
企業名稱:韓國Cosmecca Korea Co., Ltd. 
 
缺陷項描述:
 
Your firm’s quality control unit failed to review and approve all drug product production and control records to determine compliance with all established, approved written procedures before a batch is released or distributed (21 CFR 211.192).
 
你們公司的質量控制部門未能審核和批準所有藥品生產和檢測記錄來確定產品在放行或銷售之前是否符合所有既定的已批準的書面程序(21 CFR 211.192)。
 
Your OTC sunscreen drug product, (b)(4), contains (b)(4) active ingredients: (b)(4).Your batch records for lot (b)(4)of this product included concentration values for these active ingredients that did not match the data found in your instruments. You used the inaccurate data reported in your batch records to calculate potency results that were within specification, and you relied on these inaccurate results to release your product. However, when we used the instrument data instead of the results in your batch records to perform the same calculations, we found that the lot was out-of-specification (OOS)(super potent) for (b)(4) active ingredients. Your quality unit did not identify this discrepancy prior to releasing this lot.
 
你們的OTC防曬藥品XX中含有XX活性成分:XX。你們XX批次的該藥品的批記錄包括有這些活性成分的濃度值,與在你們儀器中發現的數據并不相符。你們使用了不準確的數據報告在你們的批記錄中用以計算得到符合質量標準的含量結果,你們依賴這些不準確的結果來放行你們的產品。但是,當我們使用儀器中的數據替代你們批記錄中的數據來進行相同的計算時,我們發現該批次的XX活性成分是OOS(超過效價)。你們的質量部門在放行此批準時并未發現此分歧處。
 
 
序號:10
 
缺陷關鍵詞:數據可靠性,捏造COA數據
 
來源:FDA警告信 
 
發布日期:20180118
 
企業名稱:日本Daito Kasei Kogyo Co., LTD., Okayama Factory
 
缺陷項描述:
 
Failure to completely report test results on certificates of analysis.
 
未在COA上完整報告檢測結果
 
During the inspection, were viewed certificates of analysis (COA) for batches of (b)(4) API that you manufactured and released between June 2011 and February 2016. Your quality control unit signed these COA, which indicated that all required tests had been conducted on these batches. However, you told our investigator during the inspection that you signed these COA without having conducted all the tests for which you reported results on these COA. For example, your COA reported the results of identity and impurities tests that you never conducted.
 
在檢查期間,我們審核了你們在2011年至2016年2月期間生產和放行的XX批次API的COA。你們的QC部門簽署了這些COA,這表示對這些批次的所有所需檢測均已執行。但是,你們在檢查期間告訴我們調查人員說你們并未執行所有檢測就獲得了這些COA上的報告結果,并簽署了這些COA。例如,你們的COA報告了鑒別結果和雜質檢測,但你們根本未進行檢測。
 
You falsified the COA you issued to your customers. Regulators and customers rely on COA for accurate information about the quality and sourcing of drugs and their components. Falsifying information about the quality of your drugs on COA compromises supply chain accountability and traceability, and may put consumers at risk.
 
你們捏造了簽發給客戶的COA。法規監管人員和客戶依賴于COA,來確認藥品及其成分的質量準確信息和來源。在COA上捏造關于你們藥品的質量信息使得供應鏈可靠性和可追溯性受到破壞,可能會將消費者置于風險下。
 
 
序號:11
 
缺陷關鍵詞:數據可靠性,歷史分析數據保存
 
來源:FDA警告信 
 
發布日期:20180109
 
企業名稱:中國湖南新合新 
 
缺陷項描述:
 
Failure to maintain complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards.
 
未能保存所有為確保你們原料藥和中間體符合既定標準而執行的實驗室檢測中生成的完整數據。
 
Your firm failed to retain and locate the analytical raw data for batches (b)(4) and (b)(4) of (b)(4)base which you shipped to the United States in 2014. In your response, you stated the “analytical data was not backed up.” You also said that you transferred the instrument that generated the data to your (b)(4) branch in 2015 and that the staff there deleted the data. It is essential to retain raw data to ensure the ability to reconstruct cGMP activities and review raw data, as necessary, for deviations and investigations.
 
你們公司未保存你們在2014年銷往美國的XX基XX批和XX批的分析原始數據。在你們的回復中,你們聲稱“分析數據沒有備份”。你們還說你們將生成這些數據的儀器于2015年轉移至你們XX分部,那兒的員工刪除了這些數據。保存原始數據以確??梢赃€原cGMP活動和在必要時如偏差及調查時對原始數據的審核是基本要求。
 
 
序號:12
 
缺陷關鍵詞:數據可靠性,批記錄
 
來源:FDA警告信 
 
發布日期:20180109
 
企業名稱:中國湖南新合新 
 
缺陷項描述:
 
Failure to prepare and use production and control records for each intermediate and API batch.
 
未為每個批次中間體和原料藥制訂并使用生產和檢驗批記錄。
 
Your Quality Unit failed to retain and locate 20 of (b)(4) of your (b)(4) base batch records, including but not limited to records for batches (b)(4) and (b)(4).In your response, you stated the batch records “are not missing” and are “archived properly.” Your response is inadequate because you did not provide evidence, such as copies of the executed batch records.
 
你們質量部門未能保存和找到20批你們的XX批產品的記錄,包括但不僅限地XX批和XX批記錄。在你們的回復中,你們聲稱批記錄“并未丟失”,而是“妥善歸檔保存”了。你們的回復是不充分的,因為你們未提交證據,如已執行批記錄的副本。
 
Additionally, your Quality Assurance department approved batch record 0220151203 and batch record0220151204 despite the inaccuracy of the weight of raw materials added. In your response, you stated the operator “did not follow the procedure” and did not recognize this as a deviation. You also stated personnel had “inadequate awareness of deviations.” It is your responsibility to ensure the accuracy and completeness of your batch records in order to establish that your manufacturing process was followed and is reproducible.
 
另外,你們的QA部分已批準了批記錄0220151203和批記錄0220151204,但所加入的原料重量是不準確的。在你們的回復中,你們聲稱操作工“未遵守程序”,并且不認為這是一個偏差。你們還聲稱人員“對偏差的了解不足”。你們有責任確保你們批記錄的準確性和完整性,以證明你們遵守你們的生產工藝,并且工藝是可重復的。
 
 
序號:13
 
缺陷關鍵詞:數據可靠性,記錄保存
 
來源:FDA 483  
 
發布日期:20180411
 
企業名稱:印度Alkem Laboratories 
 
缺陷項描述:
 
In addition, your firm failed to maintain and retain logbooks that are not obsolete or outdated. For example, once completed your firm destroys logbooks from the following areas: (b)(4) block warehouse, Housekeeping (b)(4)-Block QC, (b)(4)-Block QA,(b)(4)-Block Manufacturing, (b)(4)-Block, QC, Warehouse, and Production-(b)(4)Block.
 
另外,你公司未維護和保存過期的臺賬記錄。例如,一旦完成,你公司即把以下區域的臺賬記錄銷毀:XX車間倉庫、庫管XX車間QC、XX車間QA、XX車間生產、XX車間、QC、倉庫和生產-XX車間。
 
As recent as 2018, the destruction of logbook examples include, but are not limited to: Notification Record for Invalid Data, Line Clearance Checklist, Preventive Maintenance, Instrument Logbooks, training records, cleaning check lists.
 
近至2018年,臺賬記錄的銷毀例子包括但不僅限于:無效數據通知記錄、清場記錄、預防性維護記錄、儀器日志、培訓記錄、清潔檢查清單。
 
 
序號:14
 
缺陷關鍵詞:數據可靠性,網絡存儲數據的刪除
 
來源:FDA 483 
 
發布日期:20180411
 
企業名稱:印度Alkem Laboratories 
 
缺陷項描述:
 
A. Your firm’s QC department deleted two-thousand one hundred one (2,101) files since 1 March 2018 on your network. These files names include, but are not limited to: OOS, OOT, Incidents, Method Verification Reports, chromatographs, calculations, and Stability Reports.
 
你公司的QC部門自2018-03-01起從你們網絡上刪除了2101個文件。這些文件名稱包括但不僅限于OOS、OOT、事件、方法確認報告、色譜、計算和穩定性報告。
 
 
序號:15
 
缺陷關鍵詞:數據可靠性,實驗室記錄
 
來源:FDA 483 
 
發布日期:20180411
 
企業名稱:印度Alkem Laboratories 
 
缺陷項描述:
 
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
 
實驗室記錄未包括為確保符合既定規格和標準而進行的所有測試、檢查和含量中生成的完整數據。使用了電子記錄,但它們無法確保其可信度、可靠度和等同于紙質記錄的效力。
 
 
序號:16
 
缺陷關鍵詞:數據可靠性,EXCEL表格不受控
 
來源:FDA 483
 
發布日期:20180411
 
企業名稱:印度Alkem Laboratories 
 
缺陷項描述:
 
A. During the inspection, we observed two (2) different QC lab analyst demonstrate the ability to change calculation function in the excel spreadsheet used for finished product testing for the following:
 
在檢查期間,我們發現2個不同的QC分析員可以修改成品檢測所用EXCEL表格中的計算功能如下:
 
(1) On 22 March 2018, we observed your QC Analyst use an uncontrolled excel spreadsheet to calculate the Average, Standard Deviation, and %RSD values for (b)(4) Tablets, Batch #(b)(4) product release testing. The use of this spreadsheet is not mentioned in any written procedure when conducting (b)(4) Product Release Testing. In addition, this excel spreadsheet is not saved or printed. Therefore, the QC Reviewer is unable to verify these calculations are correct and the correct formula was used.
 
2018-03-22,我們發現你們QC分析員使用了一個未受控的EXCEL表格來計算XX片劑XX批號產品放行測試中的平均值、標準偏差和%RSD值。在所有書面程序中均未提及實施XX產品放行測試中使用此表格。另外,該EXCEL表格并未保存或打印。因此,QC復核人員無法確認這些計算是否正確,所用公式是否正確。
 
(2) On 23 March 2018, we observed the QC Reviewer use an uncontrolled excel spreadsheet to verify the potency of (b)(4) working standard during the Analytical Worksheet review for (b)(4) Tablets, Batch #(b)(4). The use of this spreadsheet is not mentioned in any written procedure when conducting Analytical Report reviews.
 
2018-03-23,我們發現該QC審核人員在審核XX片劑XX批號的分析工作表過程中使用了未受控的EXCEL表格來核實XX工作標準的效價。在所有書面程序中均未提及在執行分析報告審核時使用此表格。
 
B. On 19 March 2018, we observed your QC Manager’s use an excel spreadsheet to track quality functions, such as stability samples. This document is not maintained through document control and there is no protection from data manipulation, overwriting, erasing of data, or audit trails.
 
2018-03-19,我們發現你們QC經理使用了一份EXCEL表格追蹤質量函數,例如穩定性樣品。此表格并未按照文件受控的原則進行維護,亦無防止數據篡改、改寫、數據擦除或審計追蹤的手段來進行保護。
 
C. On 19 March 2018, during the inspection, we observed two (2) (b)(4) employees use an uncontrolled spreadsheet to calculate due dates used during the manufacturing and packaging of drug products.
 
2018-03-19,在檢查期間,我們發現2個XX員工使用了未受控表格來計算藥品生產和包裝中所用的有效期。
 
(1) For example, but not limited to, the (b)(4) stage is to be completed within (b)(4) initiating the compressed tablet stage. However, the dates used to calculate these timeframes has not been validated. In addition, this spreadsheet was no password protected.
 
例子包括但不限于,XX步驟是在壓片開始之后XX時間內完成。但是用于計算這些時間的日期并未經過驗證。此外這些表格亦無密碼保護。
 
 
序號:17
 
缺陷關鍵詞:數據可靠性,原始數據 實驗室記錄
 
來源:FDA 483  
 
發布日期:20180411
 
企業名稱:印度Alkem Laboratories 
 
缺陷項描述:
 
Established laboratory control mechanisms are not documented at the time of performance.
 
在進行實驗室檢測時未未按既定的實驗室控制機制進行記錄。
 
Specifically, 具體來說
 
A. During our inspection of the QC laboratory on 19 March 2018, we observed your QC Analyst entering data electronically into an excel spreadsheet, in the absence of raw data. This same data was also entered into the 9M Stability Study Logbook for (b)(4) Tablets (b)(4)mg, Batch #(b)(4), manufactured April 2017 (2months late).
 
2018-03-19我們對QC實驗室檢查期間,發現你們QC分析員將電子數據錄入到一個EXCEL表格中,而沒有原始數據。同樣的數據亦被錄入生產日期為2017年4月的XX片劑XX批號的9個月穩定性研究登記本(延遲2個月)。
 
B. On 23 March 2018, we observed a QC Executive reviewing an OOS/OOT investigation for(b)(4) mg Tablets, Batch #(b)(4) where the stability and scoring study were OOT. The employee had a pen for signing for the review, but no checklist, paper, or workstation for recording errors. In the event of an error the employee reported, they would notify the Section Head and Analyst, but not document it.
 
2018-03-23,我們發現一位QC經理正審核一份XX片劑XX批號的OOS/OOT調查,該穩定性和分級調查為OOT。該員工有一支鋼筆用于審核簽字,但并沒有檢查清單、紙或工作站來記錄錯誤。在員工報告錯誤時,他們就口頭通知分區領導和分析員,無紙質記錄。
 
C. On 23 March 2018, we observed an Analytical Worksheet for Raw Materials for (b)(4), Batch #(b)(4), did not contain any data for the UV conducted on 13 March 2018. The QC Analyst that conducted this analysis stated he did not document these recordings on the Analytical Worksheet because his data packet was removed by other Analysts without his knowledge.
 
2018-03-23,我們發現一個XX產品XX批號原料的分析記錄中并無2018-03-13所進行的UV檢測數據。執行此檢測的QC分析員聲稱他并未將這些記錄在分析記錄上,因為他的數據包在他不知情的情況下被別的分析員清除了。
 
D. On 22 March 2018, we observed a manufacturing employee entering tablets weights non-contemporaneously during the manufacturing of (b)(4) tablets USP (b)(4)mg, Batch # (b)(4) in the (b)(4) Block building.
 
2018-03-22,我們發現一位生產員工在XX車間生產XX批次的XXmg USP規格的XX片劑時,未同步錄入片劑重量。
 
 
序號:18
 
缺陷關鍵詞:數據可靠性,人員權限
 
來源:FDA 483
 
發布日期:20180411
 
企業名稱:印度Alkem Laboratories 
 
缺陷項描述:
 
All processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate the phase of processing of the batch. Electronic signatures based on are used, but they do not meet the requirements of 21 CFR Part 11.
 
所有用于一個批次藥品生產的生產線和主要設備未進行恰當識別以顯示其所適用的批處理階段。使用了電子簽名,但不符合21CFR第11部分要求。
 
Specifically, 具體來說
 
A. Your firm uses Programmable Logic Controllers (PLC) equipment during the manufacturing of drug products, which require a password and user name to operate. Your firm uses the following manufacturing PLC equipment that are not password protected:
 
你公司在藥品生產中使用了PLC設備,需要一個密碼和用戶名來操作。你公司使用了以下生產PLC設備,但無密碼保護:
 
 
序號:19
 
缺陷關鍵詞:數據完整性,缺少事件報告
 
來源:FDA 483
 
發布日期:20180321
 
企業名稱:Dr. Reddy’s 
 
缺陷項描述:
 
The Empower 3 audit trail used in the QC laboratory for data acquisition system revealed on 2018-02-14 that Sample Set ID 2793, Sample Method #14318050 was aborted after injection #6 during system suitability for Agilent HPLC #QC-143, Per SOP #GQA032-01 (Handling of Incidents) 2017-09-15 effective date, an incident report is to be raised. However, at the time of the inspection no incident report was generated or explanation was documented on why this sample set was aborted.
 
QC用作數據采集系統的Empower 3的審計追蹤顯示在2018-02-14有一個進樣序列號為2793,樣品方法#14318050在Agilent HPLC #QC-143系統適用性運行中#6針進樣后被中斷,依SOP #GQA032-01(事故處理),生效日期2017-09-15,應提交一份事件報告。但是,直到檢查時都沒有填寫事件報告,也沒有文件記錄為什么要中止這個進樣序列。

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