Process safety groups in the pharmaceutical industry are important components of active pharmaceutical ingredient (API) development through its life cycle from discovery to commercial scale. The pharmaceutical process safety laboratory staff conduct a series of tests to identify chemically unstable reagents, intermediates and solvents, and mixtures to ensure that the proposed operating conditions provide a sufficient safety margin from the onset of undesired and potentially catastrophic thermal decomposition. Across several pharmaceutical companies, the methods used for these assessments and how results and conclusions are made are widespread (vide infra). A working group was created with members from several pharmaceutical companies within the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), with the goal of precompetitive collaboration and to understand each of the participating companies’ procedures and assessment regarding process safety. Each company was invited to provide input using a blind survey format. This was done in the interest of making this knowledge accessible for the participating companies and the wider community of other pharma and chemical companies and even academic institutions in the US and throughout the world. This article provides the results of this in-depth survey of the members of the IQ Consortium thermal hazard working group. General issues around different tools used to assess thermal hazard risk and questions regarding staffing and tech transfer of process safety data/information from development to manufacturing were addressed. A snapshot of how various assessment strategies are employed as a function of stage of development (early, mid, and late) is also presented.

中文翻译：

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制药行业的过程安全性-第一部分：热和反应危害评估过程和技术

从发现到商业规模的整个生命周期，制药行业中的过程安全组都是活性药物成分（API）开发的重要组成部分。制药过程安全实验室人员进行了一系列测试，以鉴定化学上不稳定的试剂，中间体和溶剂以及混合物，以确保建议的操作条件从发生不希望的和潜在的灾难性热分解时开始提供足够的安全裕度。在几家制药公司中，用于评估的方法以及如何得出结果和结论是很普遍的（见下文））。在国际药品开发创新与质量联盟（IQ）中，由几家制药公司的成员组成了一个工作组，其目的是进行竞争前的合作，并了解每个参与公司的流程安全性和评估。邀请每个公司使用盲目调查格式提供意见。这样做是为了使参与公司以及其他制药和化学公司乃至美国乃至全世界的学术机构的广大社区都可以访问此知识。本文提供了对IQ财团热危害工作组成员进行的深入调查的结果。解决了用于评估热危害风险的各种工具的一般性问题，以及有关人员安全和从开发到制造的过程安全数据/信息的技术转移问题。还简要介绍了如何根据开发阶段（早期，中期和后期）采用各种评估策略。