An AAPS joint face-to-face meeting was held on April 6th, 2016 at MedImmune, Gaithersburg, MD. The meeting was organized by members of the Steering Committees of the Stability Focus Group, the Pharmaceutical Impurities Focus Group and the Chemistry, Manufacturing and Controls (CMC) Statistics Focus Group. Twenty two subject-matter-experts (SME) from the Industry and the Food & Drug Administration (FDA) participated as discussion facilitators or discussion leaders. The total participants reached 65 people representing various sizes of pharmaceutical companies. Four contemporary technical topics on analytical approaches to ensure product quality were selected to be discussed and shared information: (1) Approaches to set release limits and managing method variability; (2) Ensure product quality through lifecycle management; (3) Best practices for predictive stability programs; and (4) ICH Guideline M7 and mutagenic impurities. The purpose of the meeting was to share the best practices in the industry related to the topics; therefore, it is not intended for the participants to reach a consensus on the key issues discussed. This paper summarizes the discussions in the meeting.

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分析方法，以确保产品质量- AAPS关节面到面的稳定，制药杂质，管委会统计焦点小组会议，4月6^日，2016年马里兰州盖瑟斯堡

AAPS联合面对面会议于2016年4月6日在马里兰州盖瑟斯堡的MedImmune举行。这次会议是由稳定性焦点小组，药物杂质焦点小组和化学，制造与控制（CMC）统计焦点小组的指导委员会成员组织的。来自行业和食品药品管理局（FDA）的22位主题专家（SME）作为讨论促进者或讨论领导者参加了会议。共有65人参加，代表了各种规模的制药公司。选择了关于确保产品质量的分析方法的四个当代技术主题进行讨论并共享信息：（1）设定释放限值和管理方法变异性的方法；（2）通过生命周期管理确保产品质量；（3）预测稳定性方案的最佳做法；（4）ICH准则M7和诱变杂质。会议的目的是分享与主题相关的行业最佳实践；因此，与会者无意就所讨论的关键问题达成共识。本文总结了会议中的讨论。