Abstract
Delivering safe products to ensure patient safety is key for the pharmaceutical industry. Therefore, thorough control strategies need to be put in place during the development and manufacturing of pharmaceutical products to avoid potential health threats. During the last decennium, regulatory authorities have put more emphasis on assessing and controlling mutagenic impurities, which has resulted in the compilation of ICH M7 guideline. In this chapter, we present possible approaches on how to comply with ICH M7 requirements, with a focus on degradation products that are formed in the final drug product upon its storage during shelf-life. In this chapter, we describe systematic strategies to proactively select and identify the degradation products that might be considered relevant for safety assessment in accordance with ICH M7.
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Acknowledgements
The authors want to thank the colleagues from “Janssen” who provided insight and expertise that contributed to the approaches outlined in this chapter. Special gratitude goes to Steven Spanhaak in providing crucial input resulting in the global impurity management policy of “Janssen”. The authors also want to thank Dr. Saranjit Singh and Dr. Sanjay Bajaj for providing the opportunity to write this chapter.
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Hostyn, S., Persich, P., Jhajra, S., Vanhoutte, K. (2018). Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities. In: Bajaj, S., Singh, S. (eds) Methods for Stability Testing of Pharmaceuticals. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-7686-7_6
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DOI: https://doi.org/10.1007/978-1-4939-7686-7_6
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