Stability Testing in Pharmaceutical Development and Manufacture

Description

New and important techniques in stability testing are facilitating product development using the Quality by Design approach. Using these it is possible to develop products more quickly and reliably, through improved methods of shelf life prediction and excipient testing. New stability testing protocols using the published ASAP method from Pfizer can generate information quickly and reliably.

The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing in a highly interactive, relaxed environment:

• Why is stability testing required for product registration and GMP purposes?
• What are the requirements for Clinical Trials, new and existing products?
• How can stability testing be applied during product development to shorten development times as well as improve product quality
• Stability testing outsourcing - successful management and execution

It will include:

• A comprehensive review of ICH stability testing guidance ICH Q1A
• Pitfalls in stability testing. Outsourcing - costs and benefits
• New approaches to stability testing including ASAP and the role of peroxides in product stability
• Stability Testing and QbD
• Workshops for attendees to present and discuss their own stability testing issues with the group

Who Should Attend?

The course is designed for people working in:

• Analytical Development
• Analytical Chemistry
• Stability Testing
• Formulation Development
• Regulatory Affairs
• Pharmaceutical & Biopharmaceutical Production
• Product Development
• Technical Operations

Course Programme

DAY 1

Introductions

• The life cycle approach to product development and Quality by Design
• Stability testing in product development

Lunch

• ICH Guidance Q1A (R2) - a comprehensive review
• Case study "Effect of Processing and Formulation Variables on the stability of a salt of a weakly basic drug candidate (tablet)" Badawy et al, BMS
• EU GMP guidance on stability testing

DAY 2

• ICH Q6 - specifications, and how to set them. Role of specifications in stability testing. Alternative approaches to deriving specifications
• Evaluation of stability data - ICH guidance Q1E. Identifying out of trend data. Alternative approaches.
• Data interpretation case studies including attendee problems

Lunch

• Bracketing and matrixing designs for stability testing of new drug substances and products - ISC Q1E
• Photostability testing - Q1B
• Action Planning and Final Q&A
• Workshop and examples based on delegate's interests

Group discussion, problem solving and consultancy

Additional Resources

Online access to comprehensive publications including all relevant guidance will be provided as well as colour copies of all presentations and case studies.