關于藥品檢驗結果oos的調查doc(編輯修改稿)

　

【文章內容簡介】 bbles were introduced during an injection on a chromatographic system, which other tests indicated was performing properly. Such theories are difficult to prove. However, a reinjection can provide strong evidence that the problem should be attributed to the instrument, rather than the sample or its preparation.如果懷疑設備瞬間的故障，那么調查可以重新進樣該溶液。如果在色譜系統一次進樣期間引入了氣泡，而其它的試驗進行正常，這是可能發生的。這樣的推測很困難去證明。但是，重新進樣能有力的證明問題與儀器有關，而不是與樣品或樣品的準備有關。! For release rate testing of certain specialized dosage forms, where possible, examination of the dosage unit tested might determine whether it was damaged in a way that affected its performance. Such damage would provide evidence to invalidate the OOS test result, and a retest would be indicated.對于某一特定制劑的放行檢驗，如果可能，檢查一下被測的這份制劑可以確定是否在什么方面被損壞而影響了其性能。這樣的損壞能提供證據使OOS檢驗結果無效，這樣就可以進行重新檢驗。! Further extraction of a dosage unit can be performed to determine whether it was fully extracted during the original analysis. Inplete extraction could invalidate the test results and should lead to questions regarding validation of the test method.對一份制劑做進一步提取以確定在初次檢驗期間是否被充分的提取了。不完全的提取能使檢驗結果無效，將導致檢驗方法驗證的問題。It is important that each step in the investigation be fully documented. The supervisor should ascertain not only the reliability of the individual value obtained, but also the significance these OOS results represent in the overall quality assurance program. 在調查的每一步都應做充分的記錄，這是很重要的。主管不僅應該確定獲得的個別值的可靠性，也應該確定在整個質量保證程序中闡明的OOS結果的重要性。Supervisors should be especially alert to developing trends.主管應該特別警惕發展趨勢。Laboratory error should be relatively rare. Frequent errors suggest a problem that might be due to inadequate training of analysts, poorly maintained or improperly calibrated equipment, or careless work. Whenever laboratory error is identified, the firm should determine the source of that error and take corrective action to ensure that it does not occur again. To ensure full pliance with the CGMP regulations, the manufacturer also should maintain adequate documentation of the corrective action.In summary, when clear evidence of laboratory error exists, laboratory testing results should be invalidated. When evidence of laboratory error remains unclear, a failure investigation should be conducted to determine what caused the unexpected results. It should not be assumed that failing test results are attributable to analytical error without performing and documenting an investigation. Both the initial laboratory assessment and the following failure investigation should be documented fully.實驗室錯誤應該是極少發生的。頻繁的錯誤暗示一個問題，那就是檢驗員培訓不充分，設備維護保養不善或沒有得到正確校正，或工作粗心。如果實驗室錯誤被確定了，企業應該確定錯誤的來源并采取糾正措施去保證錯誤不再發生。為保證完全符合CGMP,生產商應該保持充分的糾正措施的記錄。總之，當實驗室錯誤的證據已經存在，實驗室檢驗結果應該作廢。當實驗室錯誤的證據仍然不清楚，應該進行不合格結果的調查以確定引起意外結果的原因。在沒有進行調查及調查文件確定之前不應該假定失敗的檢驗結果屬于檢驗錯誤。最初的實驗室評估和下面的不合格結果的調查應該被充分的記錄。IV. INVESTIGATING OOS TEST RESULTSOOS結果調查When the initial assessment does not determine that laboratory error caused the OOS result and testing results appear to be accurate, a fullscale failure investigation using a predefined procedure should be conducted. The objective of such an investigation should be to identify the source of the OOS result. Varying test results could indicate problems in the manufacturing process, or result from sampling problems. Such investigations present a challenge both to employees and to management and should be given the highest priority.如果最初的評估不能確定是實驗室錯誤造成了OOS結果且實驗結果是正確的，應按照預先確定的程序進行全方位的不合格調查。這樣調查的目的是確定OOS結果的來源，變化的試驗結果可能顯示是生產工藝的問題或取樣問題導致的結果。這樣的調查是對員工和管理者的挑戰應給予極高度的重視。The investigation should be conducted by the quality control unit and should involve all other departments that could be implicated, including manufacturing, process development, maintenance, and engineering. Other potential problems should be identified and investigated.調查應該由質量控制部門和所有其它相關的部門完成，包括生產部門，工藝研發部門，維護保養和工程部門。其它的潛在問題也應該被確定和調查。The records and documentation of the manufacturing process should be fully investigated to determine the possible cause of the OOS results.應該充分調查生產過程的記錄和文件以判斷引起OOS結果的可能原因。A. General Investigational Principles一般調查原則A failure investigation should consist of a timely, thorough, and welldocumented review. 一個不合格結果的調查在于及時，徹底，和完善的記錄審核 。The written record should reflect that the following general steps have been taken. 記錄應該反映通常采取的下列步驟：1. The reason for the investigation has been clearly identified.調查的原因被清楚的確定。2. The manufacturing process sequences that may have caused the problem should be summarized.對可能引起問題的生產工藝流程進行了總結。3. Results of the documentation review should be provided with the assignment of actual or probable cause.文件審核的結果提供了實際的或可能的原因。4. A review should be made to determine if the problem has occurred previously.審核并判斷是否以前發生過這類問題。5. Corrective actions taken should be described.應該描述采取的糾正措施The general review should include a list of other batches and products possibly affected and any required corrective actions taken including any ments and signatures of appropriate production and quality control personnel regarding any material that may have been reprocessed after additional testing.一般性審核應該包括可能受影響的其它批和產品的列表，任何必須的糾正行為包括對復檢后進行返工的物料的適宜的生產和質量控制人員的評論和簽名。B. Laboratory Phase of an Investigation 實驗室階段的調查A number of practices are used during the laboratory phase of an investigation. These include: (1) retesting a portion of the original sample, (2) testing a specimen from the collection of a new sample from the batch, (3) resampling testing data, and (4) using outlier testing.在實驗室階段的一系列調查包括：（1）最初樣品一部分的再檢驗，（2）從該批中重新取樣樣品的檢驗，（3）重新取樣的檢驗數據，（4）逸出值的檢驗1. Retesting重新檢驗Part of the investigation may involve retesting of a portion of the original sample. The sample used for the retesting should be taken from the same homogeneous material that was originally collected from the lot, tested, and yielded the OOS results. For a liquid, it may be from the original unit liquid product or posite of the liquid product。 for a solid it may be an additional weighing from the same sampl