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藥品研究中g(shù)lp實(shí)驗(yàn)室實(shí)驗(yàn)原始記錄審核技術(shù)要求(已修改)

2025-06-07 18:20 本頁面
 

【正文】 藥品研究中 GLP實(shí)驗(yàn)室 實(shí)驗(yàn)原始記錄審核技術(shù)要求 龔兆龍博士 資深副總裁兼首席技術(shù)官 昭衍新藥研究中心 1 新藥研發(fā)過程 2 新藥研發(fā)過程質(zhì)量規(guī)范 GLP 歷史沿革 遵從 GLP 的意義 GLP 規(guī)范基本要求 原始數(shù)據(jù)核查要點(diǎn) 非臨床實(shí)驗(yàn)室常見錯(cuò)誤 法規(guī)對(duì) GLP 或非 GLP的要求 案例分析 內(nèi)容提要 4 GLP 歷史 – 美國 What prompted US FDA to issue GLP regulations? In the 1960s and 1970s, in addition to the “Thalidomide” story, FDA found: ? Selectively submitted findings ? Fabricated data ? Falsified data ? Discrepancies in reporting (., between individual and summary data) ? Poor laboratory recordkeeping (resulting in inability to reconstruct study performance) GLP 歷史 – 美國 In the 1960s and 1970s, FDA also found: ? No protocols, protocols written after study performance, study not performed according to protocol ? No one in charge of studies ? Sloppy laboratory practices US FDA GLP 法規(guī) 1976 Congressional hearings ? GLPs proposed 1978 ? GLPs finalized 1979 ? GLPs bee effective US FDA GLP 法規(guī) 21 CFR: Code of Federal Regulations, Food amp。 Drug Administration. 21 CFR Part 58: Good Laboratory Practices for Nonclinical Laboratory Studies 21 CFR Part 11: Electronic Records。 Electronic Signatures US FDA GLP Part 58 要求 ? Describes requirements for conducting and reporting nonclinical laboratory studies – Intent: provides a framework for conducting wellcontrolled studies ? assures quality and integrity of the data ? facilitates study reconstruction ? provides overall accountability ? Nonclinical studies that evaluate safety must be GLP pliant US FDA GLP 檢查 FDA GLP檢查過的美國國內(nèi)實(shí)驗(yàn)室 200余家 , CRO, 藥廠 US FDA GLP 檢查 FDA GLP檢查過的美國境外實(shí)驗(yàn)室 40余家 , CRO, 藥廠 US FDA GLP 檢查: MOU 8 個(gè)國家 日本 法國 德國 加拿大 意大利 瑞典 瑞士 荷蘭 US FDA GLP 檢查:中國 GLP實(shí)驗(yàn)室 2022 年 7月檢查了三家 GLP實(shí)驗(yàn)室 國家安評(píng)中心 (NCSED) 昭衍( JOINN) Bridge (康龍化成 ) 昭衍提交的試驗(yàn)報(bào)告獲得美國 FDA 認(rèn)可 , 用于支持美國的臨床試驗(yàn)。 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(hào)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(hào)) 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(cè)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(duì)中國 CRO來說,研究報(bào)告可以得到國際認(rèn)可。 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。 document ? Memoranda ? Notes ? Computer printouts ? All munications (internal/external/sponsors) GLP 規(guī)范要素 Organization and Personnel ?Education ?Training ?Experience ?Job description Personnel Management Study Director QAU ?Follow protocol ?Document deviations ?Archive GLP 規(guī)范要素 Organization and Personnel Review QAU Personnel Study Director ?Master schedule sheet ?Protocols ?Inspection records ?SOPs Management Status report Final study report GLP 規(guī)范要素 Facilities Nonclinical laboratory Receipt and storage Mixing GLP現(xiàn)場核查 Processoriented quality data as a result of proper utilization of and control over facilities, personnel and procedures Allows flexibility in laboratory operation and use of scientific judgment study directors must exert this judgment overall responsibility for technical conduct, interpretation and reporting 現(xiàn)場核查要點(diǎn) Step 1: Inventory Documents 文件清單 ? Make sure necessary documents were included in the study report – Protocol – Protocol amendments 方案修改 – Protocol deviations 方案偏離 (with explanations on possible impact to study interpretation and validity) – Report (with sufficiently detailed summary and individual animal data) 現(xiàn)場核查要點(diǎn) Step 2: Identify test article 供試品 ? test article code or name ? salt form ? formulation ? purity
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