Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management

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 of these 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. Quality leaders speaking globally with “One Voice of Quality” are essential for solving this difficult problem. This concept paper has been developed under the sponsorship of a group of Chief Quality Officers (Heads of Quality) from >25 global pharmaceutical companies and has been endorsed by the Parenteral Drug Association. The intent of this concept paper is to develop and implement aligned, standard solutions within the industry, leveraging the core foundation of the pharmaceutical quality system, such that a transformational shift can be achieved with faster implementation of new knowledge, continual improvement, and innovation through post-approval changes.

LAY ABSTRACT: Pharmaceutical manufacturers must make changes to their products and manufacturing processes over time as they incorporate new technology and new information. Because drug products are highly regulated in every country, the manufacturer must often contact national drug regulators before making these changes, even if the manufacturer is confident, based on testing and process controls, that the change will not have a negative impact on product quality or patient safety. For a product that is globally marketed, the manufacturer may have to contact dozens of regulators before making a change. This paper suggests that industry work together to identify ways to demonstrate to regulators that product and process knowledge as well as pharmaceutical quality systems are strong enough that the manufacturers should be allowed to manage some post-approval changes themselves.