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

Anders Vinther; Emma Ramnarine

doi:10.5731/pdajpst.2019.010827

Abstract

Post-approval changes are inevitable and necessary all through 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 prior to implementation. Due to the global regulatory complexity, individual post-approval changes usually take years for full worldwide approval even when they reduce risk to patient, 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 highest challenge and risks in their daily operations due to this post-approval change complexity. A global problem needs a global solution. Quality leaders speaking globally with ″One Voice of Quality″ is essential to solve this wicked problem. This concept paper has been developed under the sponsorship of a group of Chief Quality Officers (Heads of Quality) from more than 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 in faster implementation of new knowledge, continual improvement and innovation through post-approval changes.

Received August 9, 2019.
Accepted August 15, 2019.

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