Stability Testing in Pharmaceutical Development and Manufacturing

Introduction

The course will cover:
The impact of the lifecycle approach on product development:

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, statistics, 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 - 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