Stability evaluation occurs at various stages during the development of a drug product. At early development stages, it is used to select formulations and packaging configurations that are most likely to give a commercially viable shelf life. At later stages, stability data from formal studies are used to justify product shelf life (in the primary pack), shipping excursions, and process hold times. This course covers the science behind stability evaluation as well as regulatory expectations.
Risk-Based Stability Evaluation of Pharmaceuticals Masterclass is a live, two-day course, which begins with an overview of the types of stability studies conducted (including predictive stability studies), followed by a review of current regulatory expectations. It is important that forced degradation studies are predictive of real-time and accelerated conditions and an approach that makes this more likely is described, including the use of a humidity-corrected Arrhenius model (Accelerated Stability Assessment Programme, or ASAP).
Within the ICH regions (Climatic Zones I and II), the Q1 stability guidelines are followed, but for companies seeking global approval for new drug products, the requirements for other regions are described. The science behind photostability evaluation is explained, together with the requirements for data trending and reduced study designs (bracketing and matrixing). The stability of biological products (ICH Q5C) is described, together with typical protein degradation pathways and analytical approaches.
Recently, the IQ Consortium has published a series of papers proposing updates to current stability guidance. They have recommended a risk-based life cycle management approach to stability evaluation for chemical drugs and biologics in line with the principles of Quality by Design (ICH Q8), quality risk management (ICH Q9) and drug product life cycle management (ICH Q12). The IQ Consortium approach focuses on understanding the risks to drug product stability and designing a formulation (including material attributes), manufacturing process and primary pack that together mitigate those risks.
Learning Objectives
Risk-Based Stability Evaluation of Pharmaceuticals Masterclass is a live, two-day course, which begins with an overview of the types of stability studies conducted (including predictive stability studies), followed by a review of current regulatory expectations. It is important that forced degradation studies are predictive of real-time and accelerated conditions and an approach that makes this more likely is described, including the use of a humidity-corrected Arrhenius model (Accelerated Stability Assessment Programme, or ASAP).
Within the ICH regions (Climatic Zones I and II), the Q1 stability guidelines are followed, but for companies seeking global approval for new drug products, the requirements for other regions are described. The science behind photostability evaluation is explained, together with the requirements for data trending and reduced study designs (bracketing and matrixing). The stability of biological products (ICH Q5C) is described, together with typical protein degradation pathways and analytical approaches.
Recently, the IQ Consortium has published a series of papers proposing updates to current stability guidance. They have recommended a risk-based life cycle management approach to stability evaluation for chemical drugs and biologics in line with the principles of Quality by Design (ICH Q8), quality risk management (ICH Q9) and drug product life cycle management (ICH Q12). The IQ Consortium approach focuses on understanding the risks to drug product stability and designing a formulation (including material attributes), manufacturing process and primary pack that together mitigate those risks.
Learning Objectives
- A deeper insight into the science behind stability evaluation
- An appreciation of the use of stability evaluation at each stage of drug development
- An understanding of how to design efficient stability studies that meet the requirements of regulatory authorities
- An understanding of how to design stability studies in line with the principles of Quality by Design
- An insight into designing a risk-based stability study
- Answers to your questions on stability studies
