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By Sherif Badawy

Sherif Badawy-finalOver the past 10–15 years, the quality by design (QbD) approach for product development has emerged as an established philosophy that has been adopted by numerous pharmaceutical companies. It has also been nearly a decade since the International Conference on Harmonisation (ICH) guidelines were first introduced. Since then, a few significant developments have taken place:

  • Pharmaceutical outsourcing has emerged as a successful business model. Due to increased competitive and market pressure to contain fixed costs, all companies are looking for ways to strategically increase their outsourcing capabilities, both at pre-approval and post-approval stages.
  • The current QbD approach is traditionally employed using process variables that tie the process to a particular equipment design (or scale) and therefore create technology transfer and post-approval challenges. Efforts are underway by scientific leaders to discuss and develop a new QbD approach that redefines a design space in terms of its “materials science” based attributes.
  • In 2014, the ICH Steering Committee endorsed the final concept paper titled Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This upcoming guideline is intended to work with ICH Q8–Q11 and is hoped to provide a framework that facilitates the management of post-approval chemistry, manufacturing, and controls changes in a more predictable and efficient manner.
  • Also, in 2014 the Manufacturing Technical Committee of the Product Quality Research Institute published a white paper that outlined important information on the common, best practices in use today in the development of high quality chemistry, manufacturing, and controls documentation. The key topics covered in this white paper include QbD, approaches, process scale-up, and process control and validation practices, among many others.

As one would imagine, a detailed understanding of these new approaches can help in bridging the gaps that exist today in applying the ICH Q8–Q11 concepts to lifecycle management. It is also anticipated that the imbibitions of these new concepts would help the practitioners to achieve some level of post-approval “operational flexibility”. These approaches should therefore, be considered as the pillars of the new QbD 2.0 approach, which should further bring pharmaceutical manufacturing in the 21st century closer to the approaches that have already been adopted in other industries such as high value ceramics, petrochemicals, and automotives.

Please join us at the MSE Open Forum: Scientific and Regulatory Considerations for Post-Approval Changes on October 27 at 7:00 pm with four speakers that will present case studies that discuss the various scientific and regulatory considerations that are currently employed for addressing post-approval challenges for solid oral dosages. The programming of this forum was designed to strike an appropriate balance between technical knowledge, strategic decision-making, and regulatory insight.

Sherif Badawy, Ph.D., is a research fellow in the Drug Product Science and Technology department of the Bristol-Myers Squibb Company. He has more than 19 years of industrial experience in drug product development.