An American Association of Pharmaceutical Scientists (AAPS) workshop on stability challenges for clinical supplies and commercial distribution of drug product that are not addressed in the International Conference on Harmonization (ICH) Quality documents was held from April 3rd – 4th, 2017 in Rockville, MD. Seventeen subject matter experts (SME), from industry and the Food & Drug Administration (FDA) presented and facilitated the round-table discussions. A total of fifty-five participants that included experienced pharmaceutical scientists, both from small and large pharmaceutical companies and service providers, benefited from the opportunity to interact face-to-face with industry partners and regulatory agency SMEs. The two-day meeting was divided into five major sections to ensure face-to-face interactions and round-table discussions between participants and SMEs: 1) statistical approaches to stability, dissolution, and shelf life testing, 2) microbiological quality of drug products, 3) strategies to support distribution, unplanned excursions, and transportation of drug products, 4) regulatory considerations on stability testing of biologics, and 5) in-use stability during clinical and commercial phases. All in all, this interactive workshop focused on challenges and successes of addressing stability concerns that affect pharmaceutical development, manufacturing, distribution, and use of drug substances/products for which no or limited ICH guidance exists. The interactive meeting provided a unique opportunity to industrial scientists and regulatory agency liaisons to facilitate the discourse on how to address stability challenges that are not addressed in harmonized guidelines: this paper summarizes those discussions.

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统一指南未解决的稳定性挑战-稳定性焦点小组的AAPS研讨会，2017年4月3日至4日在马里兰州罗克维尔

美国药物科学家协会（AAPS）研讨会于2017年4月3日至4日在美国马里兰州罗克维尔举行，主题为国际协调会议（ICH）质量文件中未涉及的临床用品和药物产品的商业化稳定性挑战。来自行业和食品药品监督管理局（FDA）的17名主题专家（SME）提出并推动了圆桌讨论。共有55名参与者，包括来自大小型制药公司和服务提供商的经验丰富的制药科学家，都从与行业合作伙伴和监管机构SME面对面互动的机会中受益。为期两天的会议分为五个主要部分，以确保参与者和中小型企业之间的面对面互动和圆桌讨论：1）稳定性，溶出度和保质期测试的统计方法，2）药品的微生物质量，3）支持药品分销，计划外旅行和运输的策略，4）生物制剂稳定性测试的监管注意事项以及5）临床和商业阶段的使用稳定性。总而言之，本互动研讨会的重点是解决影响药品开发，生产，分销和使用的药物物质/产品的稳定性问题所面临的挑战和成功，而这些问题尚无ICH指南或指南对此没有限制。