FDA 产品质量的风险评估原则(翻译)
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2
前提: 工艺中的风险和患者的风险的联系已 丢失.
cGMP
患者
相互关系? 模型?
工艺检查风险 质量(患者)因素
风险
风险
3
目标: 重新将cGMP(PQ)风险和对患者的实际 风险联系起来
cGMP
患者
工艺检查中的风险 质量(患者)因素
风险
风险
4Байду номын сангаас
问题…
Can Risk Management theory, tools, practice and philosophy be employed to re-link risks to the patient with the risks identified, perceived or otherwise implicated in product quality terms?风险管理理论,工具,实 践和哲学
Risk Assessors
Pose the risk question.
Charge the Risk Assessors with the Risk Assessment Task.
Convene stake holders.
Analyze decision options.
Make/recommend the decision.
8
风险 = “暴露程度相对于 损失的机会”
(或者, 风险 = “chance of losing something
we value”)
风险 = 危害 x 暴露程度
风险后果 = 危害 x 暴露程度
9
同时期的风险分析
主要包括四大行动: 危害识别 风险评估 风险管理 风险交流
10
风险管评估先于风险管理
总前提和问题 风险分析的基本要素 实施PQ的风险评估的可能阶段 实施的风险分级模式? 中试放大 结论
The opinions and ideas presented here are those of the author and do not represent policy or opinion of the FDA. This material is intended for discussion purposes only.
5
Getting Started…
What theories, tools and lessons learned in risk analysis can help address these questions?
Given the need for a significant shift in the approach to risk management, how do we begin the change process? Are there off-the-shelf models and tools that might be used, i.e., at a pilot-scale? What kinds of RM processes can be used to foster changes needed both the regulatory and industrial spheres?
11
风险评估需要问以下问题:
什么会出错? 出错的可能性是什么? 后果是什么?
12
风险管理需要问以下问题:
可以做什么? 那些方法是可用的? 就风险、利益和成本而言什么是风险的交
易物? 目前的对将来的管理决定的影响是什么?
13
Roles/Tasks (--short list)
Risk Managers
基于产品质量的风险评估原 则
H. Gregg Claycamp, Ph.D., CHP Center for Veterinary Medicine Office of New Animal Drug Evaluation hclaycam@cvm.fda.gov June 25, 2003
1
提纲
Various paradigms exist for the execution of a risk assessment in public health; however, all paradigms have in common fundamental scientific principles.
6
基本风险分析
7
Starting with the Some Basics
Risk is intuitive and familiar to everyone, yet few among us define risk carefully and formally enough for complex risk analysis.
14
风险评估
Regulatory Policy Risk Assessment: (e.g., Biotechnology RA to determine the need for risk management regulation.)
How can we share a common language about risk, risk management,and science-based decision making so that we can focus on developing a high-quality risk management model for product quality?
Risk assessment is not a single process, but “a systematic approach to organizing and analysing scientific knowledge and information” to support a risk decision. NRC (1994)
Identify data and gather information on the nature, extent, magnitude and uncertainty of the risk.
Write the Risk Assessment.
Recommends changes to RM questions.
前提: 工艺中的风险和患者的风险的联系已 丢失.
cGMP
患者
相互关系? 模型?
工艺检查风险 质量(患者)因素
风险
风险
3
目标: 重新将cGMP(PQ)风险和对患者的实际 风险联系起来
cGMP
患者
工艺检查中的风险 质量(患者)因素
风险
风险
4Байду номын сангаас
问题…
Can Risk Management theory, tools, practice and philosophy be employed to re-link risks to the patient with the risks identified, perceived or otherwise implicated in product quality terms?风险管理理论,工具,实 践和哲学
Risk Assessors
Pose the risk question.
Charge the Risk Assessors with the Risk Assessment Task.
Convene stake holders.
Analyze decision options.
Make/recommend the decision.
8
风险 = “暴露程度相对于 损失的机会”
(或者, 风险 = “chance of losing something
we value”)
风险 = 危害 x 暴露程度
风险后果 = 危害 x 暴露程度
9
同时期的风险分析
主要包括四大行动: 危害识别 风险评估 风险管理 风险交流
10
风险管评估先于风险管理
总前提和问题 风险分析的基本要素 实施PQ的风险评估的可能阶段 实施的风险分级模式? 中试放大 结论
The opinions and ideas presented here are those of the author and do not represent policy or opinion of the FDA. This material is intended for discussion purposes only.
5
Getting Started…
What theories, tools and lessons learned in risk analysis can help address these questions?
Given the need for a significant shift in the approach to risk management, how do we begin the change process? Are there off-the-shelf models and tools that might be used, i.e., at a pilot-scale? What kinds of RM processes can be used to foster changes needed both the regulatory and industrial spheres?
11
风险评估需要问以下问题:
什么会出错? 出错的可能性是什么? 后果是什么?
12
风险管理需要问以下问题:
可以做什么? 那些方法是可用的? 就风险、利益和成本而言什么是风险的交
易物? 目前的对将来的管理决定的影响是什么?
13
Roles/Tasks (--short list)
Risk Managers
基于产品质量的风险评估原 则
H. Gregg Claycamp, Ph.D., CHP Center for Veterinary Medicine Office of New Animal Drug Evaluation hclaycam@cvm.fda.gov June 25, 2003
1
提纲
Various paradigms exist for the execution of a risk assessment in public health; however, all paradigms have in common fundamental scientific principles.
6
基本风险分析
7
Starting with the Some Basics
Risk is intuitive and familiar to everyone, yet few among us define risk carefully and formally enough for complex risk analysis.
14
风险评估
Regulatory Policy Risk Assessment: (e.g., Biotechnology RA to determine the need for risk management regulation.)
How can we share a common language about risk, risk management,and science-based decision making so that we can focus on developing a high-quality risk management model for product quality?
Risk assessment is not a single process, but “a systematic approach to organizing and analysing scientific knowledge and information” to support a risk decision. NRC (1994)
Identify data and gather information on the nature, extent, magnitude and uncertainty of the risk.
Write the Risk Assessment.
Recommends changes to RM questions.