中文
· 第十三條 檔案保管的設(shè)施應(yīng)當(dāng)符合以下要求： （一）防止未經(jīng)授權(quán)批準(zhǔn)的人員接觸檔案； （二）計算機化的檔案設(shè)施具備阻止未經(jīng)授權(quán)訪問和病毒防護等安全措施； （三）根據(jù)檔案貯藏條件的需要配備必要的設(shè)備，有效地控制火、水、蟲、鼠、電力中斷等危害因素； （四）對于有特定環(huán)境條件調(diào)控要求的檔案保管設(shè)施，進行充分的監(jiān)測。 |
· Section II 3.4. Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration. 10.3 Only personnel authorised by management should have access to the archives. |
· 58.51 Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies. · 58.190 (b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations. |
均要求機構(gòu)應(yīng)有檔案設(shè)施，但 · OECD要求由管理層授權(quán)進入檔案室，而CFDA與FDA未指明由誰授權(quán)； · CFDA要求對特定環(huán)境條件進行充分的監(jiān)測，而OECD與FDA未提出明確要求； · CFDA列出對計算機化的檔案設(shè)施的要求，而OECD與FDA未提出明確要求； · FDA此處有提及中期報告，而CFDA與OECD未出現(xiàn)過中期報告； · FDA規(guī)定可以使用外包檔案室；OECD No.15 4.3部分規(guī)定可以使用外包檔案室；CFDA未見外包檔案室相關(guān)描述。 |
· 第四十一條 專題負責(zé)人應(yīng)當(dāng)確保研究所有的資料，包括試驗方案的原件、原始數(shù)據(jù)、標(biāo)本、相關(guān)檢測報告、留樣受試物和對照品、總結(jié)報告的原件以及研究有關(guān)的各種文件，在研究實施過程中或者研究完成后及時歸檔，最長不超過兩周，按標(biāo)準(zhǔn)操作規(guī)程的要求整理后，作為研究檔案予以保存。 |
· Section II 10.1 The following should be retained in the archives for the period specified by the appropriate authorities: a) The study plan, raw data, samples of test and reference items, specimens, and the final report of each study; |
· 58.190 Storage and retrieval of records and data (a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained. |
要求歸檔的材料基本一致，不一致之處： · CFDA要求歸檔方案和報告的原件，而OECD與FDA并未要求原件； · FDA列出了不需要歸檔的樣本：致突變測試中獲得的樣本；血液、尿液、糞便和生物體液樣本； · CFDA要求歸檔相關(guān)檢測報告，而OECD與FDA并未要求； · CFDA與OECD要求歸檔留樣受試物和對照品，而FDA未要求。但FDA 58.105章節(jié)(d)規(guī)定對于持續(xù)時間超過4周的項目，受試物和對照品的留樣保留時間按照58.195章節(jié)規(guī)定執(zhí)行； · CFDA與FDA要求歸檔研究相關(guān)文件，OECD未要求； · CFDA要求在研究實施過程中或者研究完成后及時歸檔，最長不超過兩周；OECD與FDA的要求不同，參見系列7 SD的職責(zé)。 |
· 第四十二條 研究被取消或者終止時，專題負責(zé)人應(yīng)當(dāng)將已經(jīng)生成的上述研究資料作為研究檔案予以保存歸檔。 |
- |
- |
· OECD在SD職責(zé)中有要求終止的項目應(yīng)歸檔。 · FDA中未提及對終止項目的要求。 |
· 第四十三條 其他不屬于研究檔案范疇的資料，包括質(zhì)量保證部門所有的檢查記錄及報告、主計劃表、工作人員的教育背景、工作經(jīng)歷、培訓(xùn)情況、獲準(zhǔn)資質(zhì)、崗位描述的資料、儀器設(shè)備及計算機化系統(tǒng)的相關(guān)資料、研究機構(gòu)的人員組織結(jié)構(gòu)文件、所有標(biāo)準(zhǔn)操作規(guī)程的歷史版本文件、環(huán)境條件監(jiān)測數(shù)據(jù)等，均應(yīng)當(dāng)定期歸檔保存。應(yīng)當(dāng)在標(biāo)準(zhǔn)操作規(guī)程中對具體的歸檔時限、負責(zé)人員提出明確要求。 |
· Section II 10.1 b) Records of all inspections performed by the Quality Assurance Programme, as well as master schedules; c) Records of qualifications, training, experience and job descriptions of personnel; d) Records and reports of the maintenance and calibration of apparatus; e) Validation documentation for computerised systems; f) The historical file of all Standard Operating Procedures; g) Environmental monitoring records. |
· 58.195 (d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by 58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of this section. (e) Summaries of training and experience and job descriptions required to be maintained by 58.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraphs (a) and (b) of this section. (f) Records and reports of the maintenance and calibration and inspection of equipment, as required by 58.63(b) and (c), shall be retained for the length of time specified in paragraph (b) of this section. · 58.81 (d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained. |
需要保留的研究檔案以外的資料基本一致，不同之處有： · FDA要求QA相關(guān)的記錄由質(zhì)量保證部保留； · FDA要求主計劃表由質(zhì)量保證部保留； · FDA未對環(huán)境條件監(jiān)測數(shù)據(jù)的保留進行規(guī)定； · 以上資料，CFDA要求定期歸檔；FDA和OECD要求歸檔。 |
- |
- |
· 58.195 (g) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. |
· FDA明確指出保留的文件可以是原件，也可以是真實副本。 |
· 第四十四條 檔案應(yīng)當(dāng)由機構(gòu)負責(zé)人指定的專人按標(biāo)準(zhǔn)操作規(guī)程的要求進行管理，并對其完整性負責(zé)，同時應(yīng)當(dāng)建立檔案索引以便于檢索。進入檔案設(shè)施的人員需獲得授權(quán)。檔案設(shè)施中放入或者取出材料應(yīng)當(dāng)準(zhǔn)確記錄。 |
· Section II 10.2 Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval. 10.3 Only personnel authorised by management should have access to the archives. Movement of material in and out of the archives should be properly recorded. |
· 58.190 (c) An individual shall be identified as responsible for the archives. (d) Only authorized personnel shall enter the archives. (e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval. · 要求一致 · OECD指出進入檔案室的人員應(yīng)獲得管理層授權(quán)。 |
· 第四十五條 檔案的保存期限應(yīng)當(dāng)滿足以下要求： （一）用于注冊申報材料的研究，其檔案保存期應(yīng)當(dāng)在藥物上市后至少五年； （二）未用于注冊申報材料的研究（如終止的研究），其檔案保存期為總結(jié)報告批準(zhǔn)日后至少五年； （三）其他不屬于研究檔案范疇的資料應(yīng)當(dāng)在其生成后保存至少十年。 |
· Section II 10.1 The following should be retained in the archives for the period specified by the appropriate authorities. |
· 58.195 (a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter. (b) Except as provided in paragraph (c) of this section, documentation records, raw data and specimens pertaining to a nonclinical laboratory study and required to be made by this part shall be retained in the archive(s) for whichever of the following periods is shortest: (1) A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drug Administration. This requirement does not apply to studies supporting investigational new drug applications (IND's) or applications for investigational device exemptions (IDE's), records of which shall be governed by the provisions of paragraph (b)(2) of this section. (2) A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to the Food and Drug Administration in support of an application for a research or marketing permit. (3) In other situations (e.g., where the nonclinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued. · OECD并未對歸檔期限作出具體規(guī)定，而是要求根據(jù)相應(yīng)的監(jiān)管機構(gòu)的要求。 · 對于未用于注冊、上市申請的項目，CFDA要求保存期限為報告批準(zhǔn)后至少五年；而FDA要求至少兩年。 · 對于用于注冊、上市申請的項目，CFDA要求藥物上市后至少五年；而FDA進行了分類，部分要求批準(zhǔn)后至少兩年，部分要求（IND’s和IDE’s）提交后至少五年。 · 非研究范疇的資料，CFDA規(guī)定應(yīng)當(dāng)在其生成后保存至少十年，其他未有規(guī)定。 |
_ |
· 第四十六條 檔案保管期滿時，可對檔案采取包括銷毀在內(nèi)的必要處理，所采取的處理措施和過程應(yīng)當(dāng)按照標(biāo)準(zhǔn)操作規(guī)程進行，并有準(zhǔn)確的記錄。在可能的情況下，研究檔案的處理應(yīng)當(dāng)?shù)玫轿蟹降耐狻?/span> |
· SectionII 10 In the absence of a required retention period, the final disposition of any study materials should be documented. |
- |
· CFDA明確了檔案期滿后的處理要求，F(xiàn)DA并未有相關(guān)規(guī)定。OECD要求對任何項目材料的處置進行記錄，處置方式應(yīng)當(dāng)是按照相關(guān)監(jiān)管機構(gòu)的要求。 |
· 第四十七條 對于質(zhì)量容易變化的檔案，如組織器官、電鏡標(biāo)本、血液涂片、受試物和對照品留樣樣品等，應(yīng)當(dāng)以能夠進行有效評價為保存期限。對于電子數(shù)據(jù)，應(yīng)當(dāng)建立數(shù)據(jù)備份與恢復(fù)的標(biāo)準(zhǔn)操作規(guī)程，以確保其安全性、完整性和可讀性，其保存期限應(yīng)當(dāng)符合本規(guī)范第四十五條的要求。 |
· Section II 10 When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation. |
· 58.195 (c) Wet specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids), samples of test or control articles, and specially prepared material, which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. In no case shall retention be required for longer periods than those set forth in paragraphs (a) and (b) of this section. |
· 對于質(zhì)量易發(fā)生變化的檔案，保留時長要求是一致的，均要求不超過有效評價期。FDA也指出該保留期限同時不能超過項目其他材料的保存期限。 · CFDA中提出電子數(shù)據(jù)的保存規(guī)定要求且與紙質(zhì)材料保存期限要求一致，而FDA與OECD No.1并未提及。 · OECD中描述了在有效期內(nèi)進行的銷毀應(yīng)進行解釋并記錄。 |
· 第四十八條 研究機構(gòu)出于停業(yè)等原因不再執(zhí)行本規(guī)范的要求、且沒有合法的繼承者時，其保管的檔案應(yīng)當(dāng)轉(zhuǎn)移到委托方的檔案設(shè)施或者委托方指定的檔案設(shè)施中進行保管，直至檔案最終的保管期限。接收轉(zhuǎn)移檔案的檔案設(shè)施應(yīng)當(dāng)嚴格執(zhí)行本規(guī)范的要求，對其接收的檔案進行有效的管理并接受監(jiān)管部門的監(jiān)督。 |
· Section II 10.4 If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s). |
· 58.195 (h) If a facility conducting nonclinical testing goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The Food and Drug Administration shall be notified in writing of such a transfer. |
· CFDA與OECD要求沒有合法繼承者時，轉(zhuǎn)移檔案；FDA無繼承者相關(guān)描述； · OECD與FDA要求轉(zhuǎn)移至委托方；CFDA要求轉(zhuǎn)移至委托方或委托方指定的檔案設(shè)施； · FDA要求書面通知FDA. |
歡迎各位同行進行勘誤及指出不足之處。
參考文獻：
[1] US FDA Good Laboratory Practice Regulations 21 CFR 58，effective June 20, 1979 and subsequent amendments
[2] OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C (97)186/Final]
[3] 國家食品藥品監(jiān)督管理總局，藥物非臨床研究質(zhì)量管理規(guī)范，2017年9月1日生效
