Pharmaceutics & Novel Drug Delivery Systems

Quality Control and Regulatory Considerations in Drug Delivery Systems

Quality control and regulatory considerations play a vital role in ensuring the safety, efficacy, and reliability of drug delivery systems. This session will focus on the importance of quality control and regulatory compliance in the development and commercialization of drug delivery systems. Quality control involves comprehensive testing, validation, and monitoring of drug delivery systems throughout their lifecycle. The session will explore quality control protocols, including analytical methods, stability studies, and release testing, to ensure product quality and consistency. Regulatory considerations are crucial to meet the standards set by regulatory agencies for drug delivery systems. Discussions will cover regulatory guidelines, documentation requirements, and the importance of adherence to Good Manufacturing Practices (GMP) and other regulatory frameworks. Attendees will gain insights into the challenges associated with quality control and regulatory compliance, including manufacturing scale-up, standardization, and global regulatory harmonization. The session will also highlight case studies and best practices in quality control and regulatory compliance for drug delivery systems, emphasizing the need for robust quality management systems and proactive engagement with regulatory authorities.