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 thes 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 seminar will demonstrate how to integrate those QbD principles into a pharmaceutical quality system.
Date: 14 June 2018
Time: 13:40 – 15:40
Venue: SAS Institute, Købmagergade 7-9, DK-1150 Copenhagen
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
Speakers:
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Torben Bygvraa Rasmussen Torben Bygvraa Rasmussen is Prinicpal Consultant, Applied Manufacturing Science, at NNE. He has more than 10 years experience in the pharmaceutical industry within areas such as product development, process and product optimization, data driven decision making, tolerance analysis (DFM/DFSS), Statistical Process Control, and statistical modeling. |
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Valérie Nedbal Valérie Nedbal, PhD, serves as JMP Senior Systems Engineer for Northern Europe at SAS Institute GmbH in Heidelberg, Germany. Prior to SAS Institute, she was Senior Field Marketing Manager for LION bioscience AG, a software company offering solutions in the Life Science Market. Nedbal holds a PhD in Biology from the German Cancer Research Center in Heidelberg, and did post-docs in Max-Delbrueck Center, Berlin-Buch and in European Molecular Biology Laboratory, Heidelberg. |