GDP良好的文件规范 presentation

1、Good Documentation Practices Thomas FeldsienA Guide to Good Documentation Practice: Medical Device Projects良好的文件处理规范（GDP）良好的文件处理规范指南：医疗器械产品 Thomas FeldsienObjectivesnProvide an overview of FDA expectations and standard industry practice of documentation skills for the development and manufacture of

2、medical devices.nIdentify Data Recorder ResponsibilitiesnIdentify Data Reviewer Responsibilities目的n提供有关FDA对于医疗器械开发和生产文件规范的期望和医疗产品生产行业有关医疗器械开发和生产文件管理的技能n确定数据记录员的职责n确定数据审核员的职责 Documentation is the key to a successful GMP/QSR audit. Documentation should be complete, accurate, legible and organized.“If

3、it is not written down, it didnt happen.” -the FDAWhen entries are made in a clear readable manner, it demonstrates to an auditor that the personnel who have completed the task have quality consciousness that will help ensure a safe and effective product.Why GDP?为什么要实行GDP？ 文件是成功通过GMP/QSR审核的关键。文件内容完整

4、、准确、清晰明了、条理分明。“If it is not written down, it didnt happen.” -the FDA 如果不写下来，文件就不存在。FDA 当一条记录通过清晰可读的方式被记录，就是在向审核员证明，完成文件记录的人员有质量意识，这种意识将协助确保生产出安全、有效的产品。Why GDP?Falsification of any quality system documentation is considered as fraud by the FDA. Any incident of falsification will result in an investig

5、ation. The following actions are usually considered falsification:The documentation of a task or observation that was not performed;The documentation of a task or observation before it was performed;The backdating of a task or observation;The discarding of original data;The recording of another pers

6、ons observations without approval.为什么要实行GDP？ 质量体系文件中有任何弄虚作假都被FDA视为欺诈行为。任何弄虚作假事件都会导致FDA的调查。 以下行为通常被视为弄虚作假： 记录的内容是某一没有发生的任务或观察； 在某一任务或观察发生事前做出记录； 提前填写某一任务或观察的日期； 不提供原始数据； 未经批准，使用、记录别人的观察资料。Original DatanPaper Formats. Controlled paper formats for recording original data include bound notebooks, sheets

7、, or logbooks.nNotebooks - A hard bound notebook which is used to record data. nLog Book - A bound book which contains an approved form to record or log data. nApproved Data Sheet - A data sheet, which has been reviewed and approved as part of method or procedure, used to record data. These sheets s

8、hould be pre-numbered and contain reviewed by signature block原始数据n文件格式记录原始数据的受控文件格式，包括笔记本、工作表及事件登记簿。n笔记本用于记录数据的硬装本子n事件登记簿内含经核准的表格、用于记录数据或事件的本子。n经核准的数据表经审核、批准成为方法或程序一部分，用于记录数据。这些数据表需事先编号，包括“审核人”签名一栏。Original Data (cont.)nComputer Generated Data. Data (observations) initially recorded by a computer an

9、d transmitted to either magnetic/optical media (tapes, disks, or CD) via automated data collection systems nRecorder Generated Computer Data. Data (observations) entered by the recorder electronically and transmitted to either magnetic/optical media (tapes, disks, or CD) or hardcopy.原始数据（续）n电脑生成的数据：

10、（观察资料）数据最初由电脑记录，接着通过自动数据收集系统转换成磁性/光学介质（如磁带、磁盘或CD碟）n记录员录入电脑数据：（观察资料）数据由记录员录入电脑，转换成磁性/光学介质（如磁带、磁盘或CD碟）或打印件。Data typesnRaw data is the first record of an original observation. These may be recorded on a variety of controlled paper formats or be computer stored first on magnetic/optical medianConsecutiv

11、e or real time indicates not before or after but as measurement, test results or investigation is proceeding.nConsecutive data. Original raw or real time data (observations) printed out or obtained as the work is being done or as the observations are being made. For example, instrument/equipment dat

12、a printouts, specimens, strip charts, temperature recording charts, readings, graphs, drawings, etc.数据类型n原始数据是指最初观察到并首次记录下来的资料。这些资料可以通过各种受控文件格式记录下来，或首先通过磁性/光学介质储存在电脑上。n连续或实时记录的资料，即正在进行测量、测试以及调查所记录的资料，而非事前或事后所记录的资料。n连续数据： 工作或观察正在进行之时所打印出来或得到的原始或实时数据。例如：仪器/设备打印数据、样本、带状图表、温度记录图、读数、曲线图、绘图等等。SignaturesA

13、legal signature consists of at least a first initial and a full last name, followed by a date. Signatures must be legible. For those with “stylized” signatures, a sample signature must be provided with the printed name elsewhere as a key or in an index.签名 合法签名中，要至少包括名的缩写和姓的简写（缩写），接着写上签名日期。签名的字迹须清晰可辨

14、。至于“个性”签名，须提供签名样本与姓名印刷本做为印证或在签名索引中列出。Recorder ResponsibilitiesnAny person making data entries must sign and date the entry. Multiple recorders should initial in the proximity of the testing they were responsible for and sign at the bottom of the page.nDocumentation of original data must be made to t

15、he notebook or data sheet in real time as the work is performed. Sign all entries on the day they were made.nDo not record someone elses work unless designated to do so. Do not assume someone elses undocumented work is complete, receive verification of its completion before proceeding.nError correct

16、ions or redlines are properly reviewed and approved记录员职责n做数据录入的记录员须签名并写明录入日期。多个记录员需在各自负责的测试记录旁写上姓名缩写，并在记录页尾签名。n原始数据须在工作进行之时实时记录在笔记本上或数据表中。所有录入的数据都要在记录当天签名。n未经批准，不得记录他人的工作数据。不得假定他人非正式记录的工作已完成，在开始记录工作之前，要得到该项工作已完成证明。n有错误修正或划红线变更都有经过审核与批准。Recorder ResponsibilitiesnBackdating of entries is not permitted

17、. nDo not use notes or scrap paper for quality system records. Record data directly on approved forms.nDo not skip portions of pages, start new pages without reference, or go back to make additional entries later (unless getting the original reviewer approvals). nDo not leave blank spaces for any in

18、formation to be recorded later. If a section does not require information, write “N/A” (not applicable), or a dash “-”.nAll entries must be made in black or blue ink (indelible). nPencil may not be used.记录员职责n不允许将录入日期提前（倒写日期）。n不得使用便笺或便条纸记录质量体系数据。直接使用经核准的表格记录数据。n不得跳过页面某一部分，在没有任何说明的情况下启用下一页；之后，不得返回增加数

19、据录入（除非得到原始记录员的同意）。n不得留空，为以后记录信息所用。不需要记录数据信息的区域，需填写“N/A”（不适用），或短划线“-”.n所有数据录入须使用（不可擦掉的）黑色笔或蓝色笔。n不可以使用铅笔记录数据。Good Documentation PracticesnIf large areas of a document are to be N/Ad, a single line may be drawn through the area with an N/A in the middle of the area. Of course, initials and a date must

20、accompany this N/A.nUse a single diagonal line over unused portions of pages between the last entry and the signature. Initial and date this line.nNever record to an unnumbered or unissued notebook, datasheet, or logbook.nCopies are labeled as copiesnDrafts are labeled as draftsnApproved documents a

21、re labeled as approved良好的文件规范n文件中大区域数据不适用，可用线划掉此区域，并在中间标明“N/A（不适用)”。当然，须N/A旁边写上姓名缩写以及日期。n在最后录入数据与签名之间未使用的区域，使用对角线划掉，并在对角线旁边写上姓名缩写及日期。n请勿于未编号或签发的笔记本、数据表以及登记簿之上记录数据。n复印件有标明“复本”。n初稿有标明“初稿”。n经核准的文件有标明“已核准”。Good Documentation PracticesnVoid any pages/spaces accidentally skipped by crossing out the entire

22、 page/space, marking the page/space “Void,” giving a short explanation and initialing the entry.nThe use of ditto marks (“ ”) for recording original data is not allowed. Arrows are acceptable when repetitive information is being recorded, for example, dates, specifications, times, etc. However, arro

23、ws are not acceptable for recording final results.良好的文件规范n对失误跳过空白地方或空白页，要划掉整个空白区域，标记为“空白”，并给予简要说明，签姓名缩写。n不允许使用同上标记(“ ”) 记录原始数据。记录重复数据信息，如日期、规格、时间等等，可用箭头标明。但是，箭头不可用于记录最终结果。Red-linenRed-lineA field change to an approved document (not original data) that defines a controlled process. nThis is not an er

24、ror correction, such as when an observation value is recorded in error.Redlines must be approved by Customer under change notice or deviation before implementation红线更改红线更改n对批准的过程控制文件（非原始数据）进行现场更改。n这不是错误修正，例如改正观察值记录错误。n在实施红线更改之前，必须经过客户做出永久或临时变更批准。Error CorrectionsnIncorrect entries must be lined out

25、with a single line, initialed and dated. Do not erase, blot out, or otherwise obscure, (i.e., no liquid paper, white out, scratch, etc.)nIt should be clear what is:nthe wrong datanthe correct datanthe reason for the correctionnthe date each was recordednthe person recording themnAny corrections must

26、 be accompanied with a detailed explanation. Write in the correct entry, initial and fully explain the correction.错误修正n用线划出不正确录入的数据，写上姓名缩写与日期。不得擦掉、（用墨水)涂掉 、或者模糊原始记录。也就是说，不能用修正液/涂改液、橡皮擦等擦掉、涂掉错误数据。n记录上一定要清楚写明：n错误数据n正确数据n修正原因n记录每项数据n记录员n每项错误修正须写明详细缘由。写上正确的数据，并详细阐明修正的缘由。Error CorrectionsnCorrections or

27、changes made after the entry has been verified must be witnessed and dated.nIf an error has been corrected before review initial and date, only the recorders initial and date are required. nIf the error is corrected on the same day or after the reviewer has signed, the reviewer must also acknowledge

28、 the correction by their initials and datenIf room is not available for corrections, reference a new page and location for the correction to be made.错误修正n在原始记录已经输入并验证后，对任何记录的修正或改变须有证人并标明日期。n在审核员签姓名缩写及日期之前修改错误，只需记录员的姓名缩写及日期。n在审核员签名同一天或之后修改错误，审核员也须写上姓名缩写及日期确定此次修正。n如果没有空白处可供填写修改内容，应使用另一页/另一处，用于错误修改。Aff

29、ixed DocumentsnItems should be permanently affixed with tape or glue. However stapling is allowed. nWhen items are affixed by tape within a page an embossing signature is required. An Embossing signature is a signature that begins on the page. The embossing signature crosses over the tape and it completed onto the item affixed.nAffixed items may be overlaid but should be staggered, if possible, and in the same orientation.nIf the supporting data is a printout is light or heat sensitive, c