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* 5、新版GMP新理念介绍 与无菌药品相关的新要求 灭菌方法 热力学灭菌 湿热灭菌 干热灭菌 辐照灭菌 环氧乙烷灭菌 除菌过滤 流通蒸汽处理不属于最终灭菌 * 5、新版GMP新理念介绍 实施GMP应基于科学和风险 任何GMP法规都不可能把药品生产方方面面的细节要求都规定清楚 对于法规没有明确规定的，企业可基于科学和风险来判断可采纳的恰当方式或方法 因产品、工艺、厂房、设备、人员的不同，企业在每件事上的具体做法都会有所不同 企业可以采用经过验证的替代方法，达到本规范的要求 * 加强沟通 共同努力 为新版GMP的实施作出贡献 * 联系方式 zhanghua@ Risk is defined as probability and Severity of harm and as the probability or severity increases the Risk and Harm increases. E.g . Inactivation , of Tetanus Toxin: If the probability of reversion due to poor inactivation is high; since the process has not been validated then the severity is high thus increasing risk exponentially. World Health Organization * * QRM starts with product Development, The product and Distribution. All these aspects of a product must be inspected. World Health Organization * * Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterization during development, upon which specifications are based, and adherence to Good Manufacturing Practices; e.g., suitable facilities, a validated manufacturing process, validated test procedure, raw material testing, in-process testing, stability testing, etc. Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterization during development, upon which specifications are based, and adherence to Good Manufacturing Practices; e.g., suitable facilities, a validated manufacturing process, validated test procedure, raw material testing, in-process testing, stability testing, etc. * 5、新版GMP新理念介绍 开发 生产 发运 患者 好的风险管理能确保产品的高质量 识别 并 控制 潜在的质量问题 风险评估 风险控制 通过: 质量风险管理 * 5、新版GMP新理念介绍 质量风险管理 风险管理的方法 基本风险管理简易办法（流程图，检查表等） 失败模式和影响分析（FMEA：Failure Mode Effects Analysis） 失败