Stability Testing in Pharmaceutical Development and Manufacture

Overview

• Why is stability required?
• What are the requirements for Clinical Trials, new products, and existing products?
• How can you ensure that your programme meets worldwide requirements?

It will include:

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

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.

Numbers in our courses are limited to ensure that participants have the opportunity for thorough discussion of the issues to be covered and individual attention from our top-ranked Speakers

Course Programme

DAY 1

Stability testing in the new world of QbD

• Stability testing and the Lifecycle approach to product development
• Formulation development
• Manufacturing

History of stability testing

• How we got to where we are
• Role of ICH

Overview of ICH guidance relevant to stability testing

• Stability testing
• Impurities
• Specifications

LUNCH

Detailed review of ICH stability testing documents ICH Q1A

Defining and setting specifications – ICH Guidance Q6A

• Preclinical
• Clinical trial
• Product registration

ASAP – a new approach to stability testing the drug product
Question and Answer session

DAY 2

Matrixing and bracketing pitfalls and purpose – ICH guidance Q1D

Quality systems issues

• Safeguarding data quality

Shelf lives and expiration dating – interpreting and using data.

• Applying ICH Guidance Q1E

Out spec and out of trend data. Assessing outliers.

LUNCH

Photostability testing of new dosage forms ICH Q1B

• History, purpose and implementation of guidance

Applications/case studies

• Case 1 syrup preformulation paper
• Case 2 tablet formulation selection
• Case 3 Definitive testing
• Case 4 Busulfan liquid

Workshop and examples based on delegate’s interests
Group discussion, problem solving and consultancy.