PQLI Application of Science- and Risk-based Approaches (ICH Q8, Q9, and Q10) to Existing Products

This paper describes progress made by the Legacy Products Task Team within the ISPE Product Quality Lifecycle Implementation (PQLI) initiative. It discusses the opportunities and the required business and technical processes to justify and deliver a quality by design (QbD) project for an existing product. A process flow is included that summarizes business, technical, and regulatory considerations. A quality risk management-based approach is suggested. Relevant case studies also are presented. Comments are welcome.