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Development of a Quality Risk Based Tool for the Selection of Regulatory Starting Materials for Commercial Drug Substance Manufacturing Processes
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2020-11-05 , DOI: 10.1021/acs.oprd.0c00341 John Lepore 1 , Tariq Mahmood 1 , Robert Hartman 1
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2020-11-05 , DOI: 10.1021/acs.oprd.0c00341 John Lepore 1 , Tariq Mahmood 1 , Robert Hartman 1
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The selection of regulatory starting materials (RSMs) is a critical step in determining where the drug substance manufacturing process begins as it relates to the submission and approval of the commercial marketing application and with it the formal expectations for Good Manufacturing Practice (GMP) processing. The determination of RSMs can be very challenging and is often subject to significant debate both within pharmaceutical manufacturing organizations and with regulatory bodies that review the commercial marketing application. The use of quality risk management (QRM) as described in ICH Q9 can help provide a process for assessing the RSM attributes and their relationship to the critical quality attributes (CQAs) of both the final drug substance and the drug product. This publication presents a standardized risk assessment tool developed by Merck & Co., Inc., Kenilworth, NJ, USA (MSD) that facilitates the RSM decision-making process on the basis of principles described in ICH Q10 and ICH Q11. The MSD RSM tool was designed to take into account the current regulatory landscape, evolved over time as the landscape dictates, while providing a systematic evaluation of the suitability of proposed RSMs to enable their judicious selection. The MSD RSM tool can be used for new chemical entities (NCEs) submitted for commercial approval or for in-line products going through postapproval changes. The MSD RSM tool provides a total score that is used to assess the alignment with the starting material selection principles in ICH Q11 and the EMA reflection paper, which was retracted by EMA after the ICH Q11 Q&A was issued. The level of alignment should generally correspond with the likelihood that an RSM will be accepted by regulatory agencies in the commercial marketing application.
中文翻译：
开发基于质量风险的工具，以选择用于商业药物制造过程的监管原材料
选择监管起始材料（RSM）是确定原料药生产过程从何处开始的关键步骤，因为它与商业营销申请的提交和批准以及对良好生产规范（GMP）处理的正式期望有关。RSM的确定可能非常具有挑战性，并且经常在制药企业内部以及与审查商业营销应用程序的监管机构进行激烈的辩论。ICH Q9中描述的质量风险管理（QRM）的使用可以帮助提供一种评估RSM属性及其与最终原料药和药品的关键质量属性（CQA）之间关系的过程。本出版物介绍了由美国新泽西州Kenilworth的默克公司开发的标准化风险评估工具（MSD），该工具可根据ICH Q10和ICH Q11中所述的原则促进RSM决策过程。MSD RSM工具的设计考虑到了当前的监管环境，并随着环境的发展而逐步发展，同时对提议的RSM的适用性进行了系统的评估，以使其能够明智地选择。MSD RSM工具可用于提交商业批准的新化学实体（NCE）或正在经历批准后变更的在线产品。MSD RSM工具提供了总分，用于评估与ICH Q11和EMA反射纸中的起始材料选择原则的一致性，该分数在ICH Q11 Q＆发出了。对齐程度通常应与商业营销应用程序中的监管机构接受RSM的可能性相对应。
更新日期：2020-11-21
中文翻译：
开发基于质量风险的工具，以选择用于商业药物制造过程的监管原材料
选择监管起始材料（RSM）是确定原料药生产过程从何处开始的关键步骤，因为它与商业营销申请的提交和批准以及对良好生产规范（GMP）处理的正式期望有关。RSM的确定可能非常具有挑战性，并且经常在制药企业内部以及与审查商业营销应用程序的监管机构进行激烈的辩论。ICH Q9中描述的质量风险管理（QRM）的使用可以帮助提供一种评估RSM属性及其与最终原料药和药品的关键质量属性（CQA）之间关系的过程。本出版物介绍了由美国新泽西州Kenilworth的默克公司开发的标准化风险评估工具（MSD），该工具可根据ICH Q10和ICH Q11中所述的原则促进RSM决策过程。MSD RSM工具的设计考虑到了当前的监管环境，并随着环境的发展而逐步发展，同时对提议的RSM的适用性进行了系统的评估，以使其能够明智地选择。MSD RSM工具可用于提交商业批准的新化学实体（NCE）或正在经历批准后变更的在线产品。MSD RSM工具提供了总分，用于评估与ICH Q11和EMA反射纸中的起始材料选择原则的一致性，该分数在ICH Q11 Q＆发出了。对齐程度通常应与商业营销应用程序中的监管机构接受RSM的可能性相对应。
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