This excerpt from "Robust CMC Process for Small Molecules" is a guide to designing robust manufacturing processes in the pharmaceutical industry. It highlights the importance of comprehensive planning, rigorous design, and continuous improvement in the development of small molecules, biologics, and dosage forms. The author stresses that a robust process development strategy is critical for ensuring that pharmaceutical products are safe, effective, and meet the highest quality standards. Key themes include proactive quality planning, risk management, process validation, and continuous improvement as crucial elements for success in the pharmaceutical development process. The article emphasizes the need to understand the product, its manufacturing process, and the regulatory landscape to ensure that each stage from discovery to commercialization is executed effectively. The author underscores the importance of embracing risk-based approaches and adopting quality-by-design (QbD) principles for achieving robust and successful drug development processes. Overall, this excerpt emphasizes the importance of meticulous process development strategies to navigate the complex journey from discovery to the market, ultimately benefiting patients worldwide.

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