药品研究中GLP实验室实验原始记录审核技术要求-龚兆龙
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In the 1960s and 1970s, in addition to the “Thalidomide” story, FDA found: • Selectively submitted findings • Fabricated data • Falsified data • Discrepancies in reporting (e.g., between individual and summary data) • Poor laboratory recordkeeping (resulting in inability to reconstruct study performance)
• assures quality and integrity of the data • facilitates study reconstruction • provides overall accountability
• Nonclinical studies that evaluate safety must be GLP compliant
GLP 历史 – 美国
In the 1960s and 1970s, FDA also found:
• No protocols, protocols written after study performance, study not performed according to protocol
US FDA GLP Part 58 要求
• Describes requirements for conducting and reporting nonclinical laboratory studies
– Intent: provides a framework for conducting well-controlled studies
• 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)
US FDA GLP 法规
21 CFR: Code of Federal Regulations, Food & Drug Administration. 21 CFR Part 58: Good Laboratory Practices for Nonclinical Laboratory Studies 21 CFR Part 11: Electronic Records; Electronic Signatures
• 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
OECD MAD （数据互认）
• 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
• No one in charge of studies • Sloppy laboratory practices
US FDA GLP 法规
1976 Congressional hearings • GLPs proposed
1978 • GLPs finalized
1979 • GLPs become effective
2009 年7月检查了三家GLP实验室 国家安评中心 (NCSED) 昭衍（JOINN) Bridge (康龙化成)
昭衍提交的试验报告获得美国FDA 认可, 用于支持美国的临床试验。
OECD GLP 规范
• Developed in 1978
– USFDA GLP provided the basis for OECD – Revised OECD principles adopted in 1997
药品研究中GLP实验室实验原 始记录审核技术要求-龚兆龙
新药研发过程
2
新药研发过程质量规范
内容提要
GLP 历史沿革 遵从 GLP 的意义 GLP 规范基本要求 原始数据核查要点 非临床实验室常见错误 法规对 GLP 或非 GLP的要求 案例分析
4
GLP 历史 – 美国
What prompted US FDA to issue GLP regulations?
US FDA GLP 检查
FDA GLP检查过的美国国内实验室
200余家, CRO, 药厂
US FDA GLP 检查
FDA GLP检查过的美国境外实验室
40余家, CRO, 药厂
US FDA GLP 检查：MOU
8 个国家
日本 法国 德国 加拿大 意大利 பைடு நூலகம்典 瑞士 荷兰
US FDA GLP 检查：中国GLP实验室
• assures quality and integrity of the data • facilitates study reconstruction • provides overall accountability
• Nonclinical studies that evaluate safety must be GLP compliant
GLP 历史 – 美国
In the 1960s and 1970s, FDA also found:
• No protocols, protocols written after study performance, study not performed according to protocol
US FDA GLP Part 58 要求
• Describes requirements for conducting and reporting nonclinical laboratory studies
– Intent: provides a framework for conducting well-controlled studies
• 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)
US FDA GLP 法规
21 CFR: Code of Federal Regulations, Food & Drug Administration. 21 CFR Part 58: Good Laboratory Practices for Nonclinical Laboratory Studies 21 CFR Part 11: Electronic Records; Electronic Signatures
• 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
OECD MAD （数据互认）
• 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
• No one in charge of studies • Sloppy laboratory practices
US FDA GLP 法规
1976 Congressional hearings • GLPs proposed
1978 • GLPs finalized
1979 • GLPs become effective
2009 年7月检查了三家GLP实验室 国家安评中心 (NCSED) 昭衍（JOINN) Bridge (康龙化成)
昭衍提交的试验报告获得美国FDA 认可, 用于支持美国的临床试验。
OECD GLP 规范
• Developed in 1978
– USFDA GLP provided the basis for OECD – Revised OECD principles adopted in 1997
药品研究中GLP实验室实验原 始记录审核技术要求-龚兆龙
新药研发过程
2
新药研发过程质量规范
内容提要
GLP 历史沿革 遵从 GLP 的意义 GLP 规范基本要求 原始数据核查要点 非临床实验室常见错误 法规对 GLP 或非 GLP的要求 案例分析
4
GLP 历史 – 美国
What prompted US FDA to issue GLP regulations?
US FDA GLP 检查
FDA GLP检查过的美国国内实验室
200余家, CRO, 药厂
US FDA GLP 检查
FDA GLP检查过的美国境外实验室
40余家, CRO, 药厂
US FDA GLP 检查：MOU
8 个国家
日本 法国 德国 加拿大 意大利 பைடு நூலகம்典 瑞士 荷兰
US FDA GLP 检查：中国GLP实验室