Editorial pubs.acs.org/OPRD
Application of ICH Q11 Principles to Chemical Process Development Research & Development. We hope this special topic issue will allow all readers to appreciate some of the challenges by application of the ICH Q11 and ICH M7 principles when developing production processes for pharmaceuticals for patients. We also encourage future papers on chemical process development and manufacturing of drug substances to continue to illustrate and share how these guidelines are applied.
any of the scientific contributions to OPR&D reflect the challenges of synthesizing starting materials, intermediates, and/or the final drug substances for pharmaceutical drug products. For some of these products, this might include submitting these processes to various health authorities around the world for regulatory approval. To further highlight the application of organic process research and development to the ever-evolving regulatory environment with the evolution of new regulatory guidances, it seemed timely to have a special topic issue illustrating some case studies for the application of ICH Q11 Development and Manufacture of Drug Substances and ICH M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in the Pharmaceuticals to Limit Potential Carcinogenic Risk to process development. These important guidelines are the result of the International Conference on Harmonization (ICH, http://www.ich.org/). This organization brings together regulatory authorities and pharmaceutical industry from Europe, Japan, the US, and so forth, with the intent of achieving greater global harmonization to ensure safe, effective, and high-quality medicines. Since the inception of ICH Q11 and ICH M7, expectations for commercial manufacturing processes of drug substances for pharmaceutical use to apply enhanced development techniques of risk assessmentsand process knowledge as in these ICH guidelineshave lacked in opportunities to share actual case studies. However, scientists share a belief that it is imperative to integrate enhanced scientific tools with fundamental process understanding during the development and lifecycle phase for any drug substance to develop robust, high-quality drug substance processes. These papers set the foundation for connecting the functional relationship between concepts like design spaces, control strategy, starting material, scale, and equipment and so forth, for the development of processes in the laboratory to the commercial scale, equipment, or manufacturing facility. The goal of this special topic issue is to illustrate leading pharmaceutical process examples with experience in obtaining regulatory approval for commercial manufacturing processes for drug substances. The issue’s main focus will be centered on impurity control as related to new regulatory guidances and include, for example: • Examples of successes and challenges faced in developing commercial manufacturing chemical processes/routes, while focused on strategies and technologies used for impurity control to meet expected quality limits of the final drug substance; • Cutting edge chemistry, new technologies, process analytical technology (PAT), alternative purification methods, and a variety of other approaches used to meet the current expectations; • Case studies on how process chemistry is developed to establish an appropriate control strategy and scientifically justified in regulatory submissions, exploring both the industrial and the regulatory scientists’ perspective. Finally, a special thanks to all of the contributors to this endeavor on bringing this regulatory twist to Organic Process
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© 2015 American Chemical Society
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Timothy Watson, Guest Editor Timothy A. Ayers, Advisory Board Member
AUTHOR INFORMATION
Notes
Views expressed in this editorial are those of the author and not necessarily the views of the ACS.
Special Issue: Application of ICH Q11 Principles to Process Development Published: August 21, 2015 899
DOI: 10.1021/acs.oprd.5b00233 Org. Process Res. Dev. 2015, 19, 899−899
