Stability Testing in Pharmaceutical Development and 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
*Specification
*Detailed review of ICH stability testing documents ICH Q1A

Analytical Method Selection and Development

LUNCH

Defining and setting specifications – ICH Guidance Q6A
*Preclinical
*Clinical trial
*Product registration

Analytical Method Validation
*Key techniques
*Method Selection
*Outsourcing of stability testing

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

Group discussion, problem solving and consultancy