Weaving A Stronger Fabric: The Criticality Of Developing Robust Analytical Methods In Harmony With Efficient Process Development At Pharmaceutical CDMOs

To ensure the highest quality and regulatory compliance in pharmaceutical development, Analytical Method Development (AMD) must be integrated with Process Development. ICH guidelines provide a framework for this integration, emphasizing the importance of understanding the product and process to ensure consistent quality. By aligning analytical methods with the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs), organizations can optimize manufacturing processes and accelerate time-to-market. This targeted approach reduces development time and costs while ensuring that the final product consistently meets its quality specifications. Professionals with expertise in both AMD and process development bring significant strategic benefits, including enhanced product quality, regulatory advantage, and long-term organizational success. Discover how AMD is a critical phase in pharmaceutical development and its successful implementation is essential for delivering high-quality products to market efficiently and effectively.