Torben Bygvraa Rasmussen and Valérie Nedbal
As stated in Q8, the ICH guidance document on pharmaceutical development, a drug product should both function according to its intended product performance and meet the needs of patients. Although the strategy for pharmaceutical development may vary from company to company (and/or from product to product), ICH guidelines encourage a systematic approach defined by quality by design (QbD) principles.
Further documentation provides an explanation of how the QbD approach should be integrated into the pharmaceutical quality system, including process design, qualification, continued process verification, risk management and validation. Although guidance on the implementation of these requirements is prevalent, many companies have not yet implemented QbD into their quality systems; regulatory agencies have made it clear this will change.
In fact, the chemistry, manufacturing and controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) have released a manual on policies and procedures (MAPP) explaining how reviewers will soon begin to enforce the requirements from these guidance documents. Additionally, in 2014, the Director of the Center for Drug Evaluation and Research (CDER) at the FDA co-authored a paper for the American Association of Pharmaceutical Scientists detailing the concept and reiterating the importance of using a QbD approach to pharmaceutical development.
This video will demonstrate how to integrate those QbD principles into a pharmaceutical quality system.
You will learn to:
- Implement QbD principles from discovery through product discontinuation.
- Apply statistics to set specifications and validate measurement systems (assays).
- Utilize risk management tools to identify and prioritize potential critical process parameters.
- Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using design of experiments (DOE).
- Establish your design space.
- Develop a control plan as part of a risk management strategy.
- Ensure your process is in (statistical) control and capable.