【正文】 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！ 。被委托機(jī)構(gòu)出具的報(bào)告書或圖譜是否為加蓋其公章的原件。 藥品注冊現(xiàn)場核查要點(diǎn)及判定原則 其他部門或單位進(jìn)行的研究、試制、檢測等工作，是否有委托證明材料。 （包括電子圖表）和照片是否保存完整，與申報(bào)資料一致。 、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。 ，實(shí)驗(yàn)動物為本單位飼養(yǎng)繁殖的，是否能提供本單位具有飼養(yǎng)動物的資質(zhì)證明及動物飼養(yǎng)繁殖的記錄。 一致。 ，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。 ，并與申報(bào)資料的記載一致。 months after the fact ? possibly immunesensitized males transferred from 107 to 113, replaced with na239。 impact on study must be determined ? SOP deviations 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Example of Documentation ? Protocol/protocol amendment ? Protocol/SOP deviations ? Animal order ? Test article receipt/information ? Test article preparation procedure ? Dose accountability (out of range?) ? Study file notes ? Veterinary requests/approval of treatment ? Environmental deviations (. light/dark cycle and humidity) observations of animals/procedures ? Data review ? Correspondence , fax, letter, telephone calls ? Reports 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Report Preparation 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Archiving ? Protocol/amendments ? Raw data ? Documentation ? Specimens ? Final report 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) SD Responsibilities for a Final Report ? Data interpretation ? Preliminary draft – audited? unaudited? ? Integration of toxicology, pathology, TK and other supportive data ? Contributing Scientist/PI reports ? Stopped/suspended programs ? GLP pliance ? Deviations and impact on data 現(xiàn)場核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) assures that: ? protocol, including any changes, is approved as specified in GLPs, and is followed ? all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified ? unforeseen circumstances, that may affect the quality and integrity of the study, are noted when they occur, and that corrective action is taken and documented 現(xiàn)場核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): Oversees GLP Compliance in laboratory ? responsible for monitoring each study for GLP pliance ? anizationally, QAU reports to test facility management ? independent of the personnel engaged in the direction and conduct of individual studies ? assures that facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLPs 現(xiàn)場核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) Oversees GLP pliance in laboratory ? keeps uptodate records of all studies scheduled/performed with master schedule at lab ? maintains copies of all study protocols 現(xiàn)場核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) ? Inspects studies – at intervals adequate to assure the integrity of the study – maintains written and properly signed records at each inspection identifying ? date of inspection ? the study inspected ? phase or segment of study inspected ? person performing inspection 現(xiàn)場核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) ? maintains written and properly signed records at each inspection identifying ? findings and problems observed during inspection ? scheduled date for reinspection, if applicable ? problems must immediately be brought to attention of study director and management 現(xiàn)場核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) ? submits periodic status reports on each study to management and study director – notes problems – notes corrective actions taken ? determines that no deviation from approved protocols or standards operating procedures were made without proper authorization and documentation 現(xiàn)場核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) ? Reviews final study report to assure that: – report accurately describes methods and standard operating procedures – reported results accurately reflect the study’s raw data ? Prepares and signs statements to be included with the final report specifying details on inspections 現(xiàn)場核查要點(diǎn)：職責(zé) Facility Operations ? Standard operating procedures (SOP) ? Complete and prehensive ? Up to date ? Sound science and practical ? Reagents and solutions ? Identity, titer/concentration, storage requirements, and expiration date ? Animal care and IACUC Major issues of data audit What do we look for while auditing a GLP lab Study Director Facility Management Quality Assurance Chemistry Pathology (Clinical and anatomical) Technical Staff Report writing Sponsor Accounting Subcontractors 非臨床實(shí)驗(yàn)室常見錯(cuò)誤 Study director ? Failure to follow protocol Most mon because everything is driven by protocol. Examples: – TA Stability determination – Environmental conditions – Exposure to test article (dosing)