【正文】 erature searches necessary? IACUC implications? ? Do you need to use a consultant/PI for the work? 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) MultiSite Studies* ? Work (. phase of a GLP study) performed at a geographically distinct site (Not a FDA GLP term) ? Assign a PI to ensure pliance with GLPs – Will sign an Acceptance of Responsibilities form – Will sign a statement to this fact upon pletion of the work ? Study director remains the single point of control and maintains responsibility for overall conduct ? Quality assurance of the test site *OECD requirement 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Study Scheduling Considerations ? Test article availability ? Animal availability/ordering ? Housing ? Trained staff ? Analytical chemistry ? Clinical pathology ? Necropsy ? Reports 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Test Article ? Calculations How much will you need? ? When is it available? ? Final doses? ? Analytical Confirmation ? Storage/handling conditions ? Certificate of Analysis (COA), MSDS, purity, stability ? Is there a dose formulation? 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Protocol – Review amp。 ，是否具有使用記錄，記錄時(shí)間與研究時(shí)間是否對應(yīng)一致，記錄內(nèi)容是否與申報(bào)資料一致。 （包括電子圖表）和照片是否保存完整，與申報(bào)資料一致。 國外 GLP檢查發(fā)現(xiàn) The German inspectorate conducted 33 GLP inspections in 21 foreign test facilities. 221 inspection reports from the years 2022 to 2022 were analyzed for GLP observations which were categorized into the ten GLP principles 國外 GLP檢查發(fā)現(xiàn) Observations Number % 1 Studies: Study Plan / Report 353 2 Insufficient Documentation / Document Handling 259 3 SOP: Administration – Use 170 4 Organization/Personnel: Personnel Records 169 5 Apparatus/Materials/Reagents/Samples: Apparatus 152 7 6 Study: Raw Data 127 7 Test and Reference Items 119 5 8 Study: Conduct 112 5 9 Electronic data acquisition/processing / IT Systems 110 5 10 Archiving: Procedures and Access / Retrieval Options 101 11 Quality Assurance: Inspection Procedures 89 4 12 Facility 85 4 13 Insufficient separation GLP / nonGLP 61 14 Insufficient Procedures Related to MultiSite Studies 56 Questions? Visit us at or contact me at Question? Contact John Gong at 13581646905 (China) or (301) 5405988 (US) Email: 謝謝！ 。 、人員、日期、數(shù)據(jù)、以及實(shí)驗(yàn)結(jié)果等是否與申報(bào)資料一致。 ，并與申報(bào)資料的記載一致。 GLP 規(guī)范要素 What is a nonclinical laboratory? In the SFDA or USFDA regulatory world, a laboratories that conduct nonclinical studies involving test articles to develop data that will be submitted to the agency in support of an application and marketing approval GLP 規(guī)范要素 Test Articles ? the SFDA/USFDAregulated product being tested GLP 規(guī)范要素 Test Systems Mouse/Rat, Guinea Pig, Rabbit, Dog (Beagle), Pig, Monkey, Primate, (Chimpanzee) The ABC of GLP Regulations Definitions Person Individual Partnership Government agency Organizational unit Corporation Scientific or academic establishment GLP 規(guī)范要素 Raw Data ? Laboratory worksheets ? Records amp。 OECD GLP 規(guī)范 ? Developed in 1978 – USFDA GLP provided the basis for OECD – Revised OECD principles adopted in 1997 ? Primary objective similar to USFDA – To ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations in the framework of harmonising testing procedures for the mutual acceptance of data (MAD) OECD MAD （數(shù)據(jù)互認(rèn)） ? Data generated in the testing of chemicals in an OECD member country in accordance with OECD Test Guidelines and OECD Principles of GLP shall be accepted in other Member countries for purposes of assessment and other uses relating to the protection of man and the environment ? OECD Member Countries – Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Korea, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States 中國 GLP發(fā)展歷史 1993年 12月，國家科委發(fā)布了 GLP（試行） 1999年 10月， SDA發(fā)布 GLP（試行） 2022年中國修訂 《 中華人民共和國藥品管理法 》 、 《 藥品法實(shí)施條例 》 ，將 GLP明確為法定要求 2022年 9月 ,SFDA頒布實(shí)施 GLP（二號令） 280 條 , 開展 GLP認(rèn)證檢查 2022年 1月 – 法規(guī)毒理實(shí)驗(yàn)強(qiáng)制要求 GLP 2022年 7月 – 3家在中國的 GLP 實(shí)驗(yàn)室接受美國 FDA檢查 中國 GLP管理規(guī)范 藥物非臨床研究質(zhì)量管理規(guī)范（局令第 2號） 2022年 9自 2022年 9月 1日起施行 共九章 45條 非臨床研究質(zhì)量管理規(guī)范認(rèn)證標(biāo)準(zhǔn) 280條 藥品注冊現(xiàn)場核查管理規(guī)定 7章、 59條、 5個(gè)附件 遵從 GLP 的意義 ? Assures quality data and data integrity ? Protects the wellbeing of subjects in clinical trials many of whom are healthy volunteers (human safety) ? Ensures that a study can be pletely reconstructed from archived records ? 對中國 CRO來說，研究報(bào)告可以得到國際認(rèn)可。ve males – protocol violated during this time period 案例分析 (2) ? The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data – final reports for studies X and Y did not discuss potential immune sensitization of male and female guinea pigs in the respective studies as circumstances that may have affected data quality and integrity 案例分析 (2) Q: ? what is the deficiency of this GLP study audited vs regulations? ? Is data acceptable for supporting safety evaluation? 案例分析 (2) ? what is the deficiency of this GLP study audited vs regulations? ? SD ? 試驗(yàn)記錄 ? 試驗(yàn)報(bào)告 ? QA ? Is data acceptable for supporting safety evaluation? ? NO?。? 案例分析 (3) Inspection at DEF Labs Findings: ? protocol called for weekly weights, but study reported biweekly weights. ? for many of the weights, the biweekly weights