On the other hand, regulatory authorities are also grappling with the increasing complexity of pharmaceutical manufacturing. Most pharmaceutical products sold in the US are manufactured outside the US. Even for those drugs that are manufactured in the US, a significant portion of the raw materials and process intermediates is imported from manufacturers outside the US. It's no wonder that "Supply Chain Management," "Accountability in a Global Environment," "Foreign Inspections," and "International Compliance" were some of the key sessions at the 2011 PDA/ FDA Joint Regulatory Conference. Implementation of quality by design (QbD) in this environment has further contributed to the need to clarify what information needs to be included in a regulatory filing and how it should be presented. FDA has addressed this gap to some extent through its ongoing QbD pilot program, but more guidance is needed from the regulatory authorities to ensure widespread successful implementation of QbD (2).
Overall, the regulatory authorities must make changes to address the drug safety dangers that the global environment poses as well as make changes to the drug review and approval processes to encourage regulatory and pharmaceutical innovation and faster product availability to patients. Regulators also must offer more flexibility regarding manufacturing changes and application supplements based on science and risk assessment, so that limited resources on both the industry and regulatory sides will be available for drug development and innovation.In this 28th article in the Elements of Biopharmaceutical Production series, the authors focus on the regulatory challenges that arise in the QbD paradigm, in particular on how review and inspection practices have been and are evolving.