Stability Testing in Pharmaceutical Development and Manufacture

Description

- an update for the 21st Century

This course has been updated to reflect the recent changes in the pharmaceutical stability testing world.

The new course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly testing area. It will include opportunities for review of specific participant problems

The course will cover:

Recent regulatory changes affecting stability including

• The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
• Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
• Product Quality Reviews and the interpretation of stability data.

Recent scientific developments with implications for stability, with a particular focus on cost reduction, shortening of development timelines, and improvements on existing interpretation systems

• ASAP - using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence - Freethink Technologies' ASAPprime
• Low level impurities and their impact on product stability
• Manipulation of tablet internal pH to improve product stability

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

The course will commence with registration and coffee at 8.30am, course proper at 9.00am and will finish at 5.00pm

Morning

Introductions

• Quality by Design and the ICH updates QQ7, Q8, Q9, Q10 and Q11 - implications for stability testing

Afternoon

• Changes to EU GMP guidance with implications for stability - Chapter 1 and Annexes
• Product Quality Review and the interpretation of stability data
• Delegate workshop - reviewing delegate-presented problems

DAY 2

Morning

• Low level impurities and their impact on drug product stability.
• ASAP - using short term, high stress testing to get accurate predictions of drug substance and drug product shelf life with high confidence using ASAPprime software
• Bracketing and matrixing and accurate data interpretation, using the "Stability" software package from Arlenda

Afternoon

• Manipulation of tablet internal pH to improve product stability
• In Silico prediction of drug degradation pathways using the Zeneth software systems
• Action Planning and Final Q&A. Delegates are encouraged to send data for analysis prior to the course

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.