A Quality By Design (QbD) Primer
The U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have collaborated over the past several years to further Quality by Design (QbD) objectives for the pharmaceutical industry. As defined by the ICH, Quality by Design is “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.”
Since initiation of QbD concepts by the FDA into its pre-market processes in July 2005, the agency has worked to refine its process for assessing quality and communicating review findings. Most notably, FDA established a pilot program in 2011 with subsequent release of two question-and-answer documents intended to provide additional information and guidance on the QbD process. Specifically in the pharmaceutical sector, Europe, Japan, and the United States – the principle regions of the ICH – have incorporated QbD concepts into their regulatory systems, and the ICH has outlined QbD in its Q8, Q9, Q10 and Q11 documents.
After FDA and EMA completed its 2011 pilot program, the two question-and-answer documents the agencies’ issued helped clarify the objectives, outlining how quality should be designed from start to finish, rather than tested, into the final product. Key topics covered in the Q&A documents included:
- The Agencies’ expectations on providing Quality Target Product Profiles (QTTPs) and Critical Quality Attributes (CQAs) in regulatory submissions
- Clarification that the use of Key Process Parameters are not supported by ICH or the FDA/EMA
- Information on manufacturing process descriptions in regulatory submissions
- The acceptable use of analytical target profiles (ATPs) for analytical methods
- Specifics on design space verification, purpose, protocol, and submissions
R.D. Laboratories is ready to assist you with your QbD requirements. Our product support services define who we are at R.D. Laboratories and we employ a wide variety of state of the art equipment and instruments that can assist in your risk-based process assessments and real-time testing requirements.