GDP良好的文件規(guī)范

1、Good Documentation Practices Thomas FeldsienA Guide to Good Documentation Practice: Medical Device Projects良好的文件處理規(guī)范（GDP）良好的文件處理規(guī)范指南：醫(yī)療器械產品 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提供有關FDA對于醫(yī)療器械開發(fā)和生產文件規(guī)范的期望和醫(yī)療產品生產行業(yè)有關醫(yī)療器械開發(fā)和生產文件管理的技能n確定數(shù)據記錄員的職責n確定數(shù)據審核員的職責 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?為什么要實行GDP？ 文件是成功通過GMP/QSR審核的關鍵。文件內容完整

4、、準確、清晰明了、條理分明。“If it is not written down, it didnt happen.” -the FDA 如果不寫下來，文件就不存在。FDA 當一條記錄通過清晰可讀的方式被記錄，就是在向審核員證明，完成文件記錄的人員有質量意識，這種意識將協(xié)助確保生產出安全、有效的產品。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.為什么要實行GDP？ 質量體系文件中有任何弄虛作假都被FDA視為欺詐行為。任何弄虛作假事件都會導致FDA的調查。 以下行為通常被視為弄虛作假： 記錄的內容是某一沒有發(fā)生的任務或觀察； 在某一任務或觀察發(fā)生事前做出記錄； 提前填寫某一任務或觀察的日期； 不提供原始數(shù)據； 未經批準，使用、記錄別人的觀察資料。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原始數(shù)據n文件格式記錄原始數(shù)據的受控文件格式，包括筆記本、工作表及事件登記簿。n筆記本用于記錄數(shù)據的硬裝本子n事件登記簿內含經核準的表格、用于記錄數(shù)據或事件的本子。n經核準的數(shù)據表經審核、批準成為方法或程序一部分，用于記錄數(shù)據。這些數(shù)據表需事先編號，包括“審核人”簽名一欄。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.原始數(shù)據（續(xù)）n電腦生成的數(shù)據：

10、（觀察資料）數(shù)據最初由電腦記錄，接著通過自動數(shù)據收集系統(tǒng)轉換成磁性/光學介質（如磁帶、磁盤或CD碟）n記錄員錄入電腦數(shù)據：（觀察資料）數(shù)據由記錄員錄入電腦，轉換成磁性/光學介質（如磁帶、磁盤或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.數(shù)據類型n原始數(shù)據是指最初觀察到并首次記錄下來的資料。這些資料可以通過各種受控文件格式記錄下來，或首先通過磁性/光學介質儲存在電腦上。n連續(xù)或實時記錄的資料，即正在進行測量、測試以及調查所記錄的資料，而非事前或事后所記錄的資料。n連續(xù)數(shù)據： 工作或觀察正在進行之時所打印出來或得到的原始或實時數(shù)據。例如：儀器/設備打印數(shù)據、樣本、帶狀圖表、溫度記錄圖、讀數(shù)、曲線圖、繪圖等等。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.簽名 合法簽名中，要至少包括名的縮寫和姓的簡寫（縮寫），接著寫上簽名日期。簽名的字跡須清晰可辨

14、。至于“個性”簽名，須提供簽名樣本與姓名印刷本做為印證或在簽名索引中列出。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記錄員職責n做數(shù)據錄入的記錄員須簽名并寫明錄入日期。多個記錄員需在各自負責的測試記錄旁寫上姓名縮寫，并在記錄頁尾簽名。n原始數(shù)據須在工作進行之時實時記錄在筆記本上或數(shù)據表中。所有錄入的數(shù)據都要在記錄當天簽名。n未經批準，不得記錄他人的工作數(shù)據。不得假定他人非正式記錄的工作已完成，在開始記錄工作之前，要得到該項工作已完成證明。n有錯誤修正或劃紅線變更都有經過審核與批準。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.記錄員職責n不允許將錄入日期提前（倒寫日期）。n不得使用便箋或便條紙記錄質量體系數(shù)據。直接使用經核準的表格記錄數(shù)據。n不得跳過頁面某一部分，在沒有任何說明的情況下啟用下一頁；之后，不得返回增加數(shù)

19、據錄入（除非得到原始記錄員的同意）。n不得留空，為以后記錄信息所用。不需要記錄數(shù)據信息的區(qū)域，需填寫“N/A”（不適用），或短劃線“-”.n所有數(shù)據錄入須使用（不可擦掉的）黑色筆或藍色筆。n不可以使用鉛筆記錄數(shù)據。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良好的文件規(guī)范n文件中大區(qū)域數(shù)據不適用，可用線劃掉此區(qū)域，并在中間標明“N/A（不適用)”。當然，須N/A旁邊寫上姓名縮寫以及日期。n在最后錄入數(shù)據與簽名之間未使用的區(qū)域，使用對角線劃掉，并在對角線旁邊寫上姓名縮寫及日期。n請勿于未編號或簽發(fā)的筆記本、數(shù)據表以及登記簿之上記錄數(shù)據。n復印件有標明“復本”。n初稿有標明“初稿”。n經核準的文件有標明“已核準”。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.良好的文件規(guī)范n對失誤跳過空白地方或空白頁，要劃掉整個空白區(qū)域，標記為“空白”，并給予簡要說明，簽姓名縮寫。n不允許使用同上標記(“ ”) 記錄原始數(shù)據。記錄重復數(shù)據信息，如日期、規(guī)格、時間等等，可用箭頭標明。但是，箭頭不可用于記錄最終結果。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紅線更改紅線更改n對批準的過程控制文件（非原始數(shù)據）進行現(xiàn)場更改。n這不是錯誤修正，例如改正觀察值記錄錯誤。n在實施紅線更改之前，必須經過客戶做出永久或臨時變更批準。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.錯誤修正n用線劃出不正確錄入的數(shù)據，寫上姓名縮寫與日期。不得擦掉、（用墨水)涂掉 、或者模糊原始記錄。也就是說，不能用修正液/涂改液、橡皮擦等擦掉、涂掉錯誤數(shù)據。n記錄上一定要清楚寫明：n錯誤數(shù)據n正確數(shù)據n修正原因n記錄每項數(shù)據n記錄員n每項錯誤修正須寫明詳細緣由。寫上正確的數(shù)據，并詳細闡明修正的緣由。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.錯誤修正n在原始記錄已經輸入并驗證后，對任何記錄的修正或改變須有證人并標明日期。n在審核員簽姓名縮寫及日期之前修改錯誤，只需記錄員的姓名縮寫及日期。n在審核員簽名同一天或之后修改錯誤，審核員也須寫上姓名縮寫及日期確定此次修正。n如果沒有空白處可供填寫修改內容，應使用另一頁/另一處，用于錯誤修改。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