Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry One-Voice-of-Quality (1VQ) Solutions

Abstract

Post-approval changes are inevitable and necessary throughout the life of a drug product−to implement new knowledge, maintain a state of control, and drive continual improvement. Many post-approval changes require regulatory agency approval by individual countries before implementation. Because of the global regulatory complexity, individual post-approval changes usually take years for full worldwide approval even when they reduce patient risk, improve compliance, or enhance the manufacturing process or test methods. This global complexity slows down continual improvement and innovation and can cause drug shortages and current good manufacturing practices compliance issues. Manufacturers that market products globally experience the greatest challenge and risks in their daily operations because of this post-approval change complexity. A global problem needs a global solution. This paper has been sponsored and endorsed by senior Quality leaders (Chief Quality Officers and Heads of Quality) from more than 25 global pharmaceutical companies who have collaborated to speak with ″One-Voice-Of-Quality″ (1VQ). The paper provides two solutions that lay the foundation for an aligned and standardized industry position on the topic of effective management of post-approval changes in the Pharmaceutical Quality System (PQS). This document represents the 1VQ standard approach for the steps necessary to establish and demonstrate an effective quality system to fully leverage a risk-based approach to post-approval changes as laid out by ICH Q10 Annex 1. Implementation of the solutions presented in this paper can help achieve a transformational shift with faster implementation of new knowledge, continual improvement, and innovation through post-approval changes.