Annex 1 Potential Opportunities to Approaches * *Note: This annex to reflects Enhance 附件1：基于法规方法对科学和风险进行改进的潜在机会 Science and Risk Based Regulatory potential 注意：本附件反映了提高法规方法的潜在机会。由各地区确定具体的法规流程。 regulatory opportunities enhance approaches. The actual regulatory process will be determined by region. Scenario 情景 1. Comply with GMPs 符合GMP 2. Demonstrate effective pharmaceutical quality system, including effective use of quality risk management principles (e.g., ICH Q9 and ICH Q10). 阐明有效的制药质量体系，包括质量风险管理原则的有效运用(如ICH Q9 和 ICH Q10). Potential Opportunity 潜在机会 Compliance – status quo 符合现状 Opportunity to: 机会 ?increase use of risk based approaches for regulatory inspections.官方检查的风险基础方法的加强使用 Page 25 of 28
3. Demonstrate product and process Opportunity to: 机会 understanding, including effective ?facilitate science based use of quality risk management pharmaceutical quality assessment; principles (e.g., ICH Q8 and ICHQ9). 促进基于科学的制药质量评估 阐明产品和工艺理解，包括质量风险管 ?enable innovative approaches to 理原则的有效运用(如ICH Q9 和 ICH process validation; 实现工艺验证的革Q10). 新方法 ?establish real-time release mechanisms. 建立实时放行机制 4. Demonstrate effective Opportunity to: 机会 pharmaceutical quality system and ?increase use of risk based product and process understanding, approaches for regulatory including the use of quality risk inspections; 官方检查的风险基础方法management principles (e.g., ICH Q8, 的加强使用 ICH Q9and ICH Q10). ?facilitate science based 阐明有效的制药质量体系及产品和工艺pharmaceutical quality assessment; 理解，包括质量风险管理原则的有效运促进基于科学的制药质量评估 用(ICH Q8，ICH Q9 和 ICH Q10). ?optimize science and risk based post-approval change processes to maximize benefits from innovation and continual improvement; 优化基于科学和风险的批准后变更流程以最大程序地利益于革新和持续改进 ?enable innovative approaches to process validation; 实现工艺验证的革新方法 ?establish real-time release mechanisms. 建立实时放行机制 附件2：ICH Q10 制药质量体系模型图
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This diagram illustrates the major features of the ICH Q10 Pharmaceutical Quality System (PQS) model. The PQS covers the entire lifecycle of a product including pharmaceutical
development,
technology
transfer, commercial manufacturing, and product discontinuation as illustrated by the upper portion of the diagram. The PQS augments regional GMPs as illustrated in the diagram. The diagram also illustrates that
regional
GMPs
apply
to
the
manufacture of investigational products.
The next horizontal bar illustrates the 下一个水平条说明了第2节中解释的产品生importance of management responsibilities 命周期所有阶段的管理职责的重要性。接着explained in Section 2 to all stages of the 的水平条列出了PQS模型中主要的PQS要product lifecycle. The following horizontal 素。这些要素应当适当并按比例应用于产品bar lists the PQS elements which serve as 生命周期的每个阶段，识别用于持续改进区
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该图举例说明了ICH Q10制药质量体系的主要特色.PQS覆盖了产品的整个生命周期,包括药物开发,技术转移,商业化生产,和产品终止，如图中上半部分所示。如图中所示，PQS增加了地区的GMP。此图也说明了地区的GMP适用于研究用产品的生产。
the major pillars under the PQS model. 域确认的机会。 These elements should be applied appropriately and proportionally to each life cycle stage recognising opportunities to identify areas for continual improvement.
The bottom set of horizontal bars illustrates 底部的水平条说明了支持者：知识管理和质the enablers: knowledge management and 量风险管理，在生命周期阶段是可用的。这quality
risk
management,
which
are 些支持者支持完成产品实现，建立和维护状
applicable throughout the lifecycle stages. 态控制，推动持续改进的PQS目标。 These enablers support the PQS goals of achieving product realisation, establishing and maintaining a state of control, and facilitating continual improvement.
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