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In any analytical laboratory that performscGMP testing, data review is required. However, to an analytical chemist that prefers benchwork, reviewing thedata of a fellow analyst is often deemed an undesirable chore.  The data reviewer rarely gets a “Thank you”for pointing out irregularities in documentation.  The role of the data reviewer is to ensurethat the laboratory analyst’s work adheres to written test methods and  established SOPs and that the conclusions arescientifically correct.  This is a heavyresponsibility that is crucial in protecting a company from significant errorsor fraudulent practices in the laboratory.

在執(zhí)行cGMP測(cè)試的任何分析實(shí)驗(yàn)室中，都需要進(jìn)行數(shù)據(jù)審查。但是，對(duì)于喜歡機(jī)械性工作的化學(xué)分析師而言，審查其他檢驗(yàn)員的數(shù)據(jù)通常是不受歡迎的苦差事。數(shù)據(jù)審查人員很少因?yàn)橹赋鑫募涗浿械牟灰?guī)范之處而獲得“感謝”。數(shù)據(jù)審查人員的作用是確保實(shí)驗(yàn)室分析人員的工作符合書(shū)面的測(cè)試方法和既定的SOP，并確保結(jié)論科學(xué)正確。這是一項(xiàng)沉重的責(zé)任，對(duì)于保護(hù)公司免受實(shí)驗(yàn)室重大錯(cuò)誤或欺騙行為的侵害至關(guān)重要。

The review of laboratory data is requiredby 21 CFR § 211.194(A)(8): “The initials or signature of a second personshowing the original records have been reviewed for accuracy, completeness, andcompliance with established standards.” This statement does not indicate how data is to be reviewed or the skillset that is required to be capable of reviewing data properly.  Common sense dictates that a data reviewershould be a person with the knowledge and experience to fully understand thedata that they are reviewing.  This“common sense” is supported by 21 CFR § 211.25(a): “Each person engaged in themanufacture, processing, packing, or holding of a drug product shall have theeducation, training, and experience, or any combination thereof, to enable thatperson to perform the assigned functions.” When GMP regulations were initially written in the 1970s, the vastmajority of laboratory raw data was recorded on paper and it was the paper thatrepresented the evidence of the work performed in laboratory.  Data review was then performed by a peer orsupervisor.

21 CFR§211.194（A）（8）要求對(duì)實(shí)驗(yàn)室數(shù)據(jù)進(jìn)行審查：“使用第二人姓名縮寫(xiě)或簽名表示對(duì)原始記錄的準(zhǔn)確性，完整性并符合既定標(biāo)準(zhǔn)進(jìn)行審查。”該聲明并未指出如何審查數(shù)據(jù)，也沒(méi)有指出用以正確審查數(shù)據(jù)的技能。常識(shí)表明，數(shù)據(jù)審查人員應(yīng)具有知識(shí)和經(jīng)驗(yàn)，以充分理解他們正在審查的數(shù)據(jù)。 21 CFR§211.25（a）支持這種“常識(shí)”：“從事藥品的生產(chǎn)，加工，包裝或保存的人員應(yīng)接受適當(dāng)足以執(zhí)行所分配職能的教育，培訓(xùn)和經(jīng)驗(yàn)或其組合。”在1970年代最初編寫(xiě)GMP法規(guī)時(shí)，絕大多數(shù)實(shí)驗(yàn)室原始數(shù)據(jù)都記錄在紙上，紙質(zhì)記錄代表了實(shí)驗(yàn)室工作的證據(jù)。然后由同行或主管進(jìn)行數(shù)據(jù)審查。

With the evolution of computerized dataacquisition systems and electronic laboratory notebooks over the past fewdecades, in conjunction with the focus on data integrity, the skill set of datareviewers has had to evolve and become more specialized.  For example, data reviewers must have a firmgrasp on how to review time/date stamps and audit trails in electroniclaboratory notebooks in order to ensure that laboratory documentation wasperformed in real time.  Additionally,data reviewers must be adept in auditing computerized laboratory instrumentsystems to ensure there is no “extra data” within the system.  As the tools to test samples has become moresophisticated, so has the skill set of the effective data reviewer.

在過(guò)去的幾十年中，隨著計(jì)算機(jī)化數(shù)據(jù)采集系統(tǒng)和電子實(shí)驗(yàn)室筆記本的發(fā)展，以及對(duì)數(shù)據(jù)完整性的關(guān)注，數(shù)據(jù)審查人員的技能已經(jīng)必須提高并變得更加專(zhuān)業(yè)。例如，數(shù)據(jù)審查人員必須牢牢掌握如何審查電子實(shí)驗(yàn)室筆記本中的時(shí)間/日期戳和審計(jì)追蹤，以確保實(shí)驗(yàn)室記錄是實(shí)時(shí)執(zhí)行的。此外，數(shù)據(jù)審查人員必須熟練執(zhí)行計(jì)算機(jī)化實(shí)驗(yàn)室儀器系統(tǒng)的審計(jì)，以確保系統(tǒng)內(nèi)沒(méi)有“遺漏數(shù)據(jù)”。隨著檢驗(yàn)樣品的工具變得越來(lái)越復(fù)雜，數(shù)據(jù)審查人員的技能要求也隨之提高。

Today’s laboratory data reviewer must havethe keen instincts of a detective and should not be willing to accept data atface value since, in any instance, there may be trouble looming below thesurface of what appears to be acceptable laboratory data.  The job of a data reviewer may be viewed as“Thankless” by those assigned the task and considered to be an afterthought byothers.  However, data reviewers serve avital role as the safety net of both the analytical laboratory chemists and thecompany that employs them.  To those whoreview analytical data in a GMP laboratory, I want to extend a big THANK YOUfor doing this “Thankless” job.

當(dāng)今的實(shí)驗(yàn)室數(shù)據(jù)審查人員必須具有敏銳的觸覺(jué)，并且不會(huì)僅從表面上接受數(shù)據(jù)，因?yàn)樵谌魏吻闆r下，看起來(lái)似乎可以接受的實(shí)驗(yàn)室數(shù)據(jù)都可能隱藏錯(cuò)誤。數(shù)據(jù)審查人員的工作可能被分配任務(wù)的人員視為“不討好”，并被其他人認(rèn)為“秋后算賬/馬后炮”。但是，數(shù)據(jù)審查人員不管在分析實(shí)驗(yàn)室還是在雇用他們的公司，都起著至關(guān)重要的作用。對(duì)于那些在GMP實(shí)驗(yàn)室中審查分析數(shù)據(jù)的人，我要表示衷心的感謝，感謝你們做這項(xiàng)“不討好”的工作。