Stability Testing in Pharmaceutical Development and Manufacturing

Introduction

The course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly and complex testing area. Previous participants say that as a result of the course they have been able to significantly reduce testing in some areas, and identified deficiencies in other areas.

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

Who will benefit:
The course is designed for people working in:
· Analytical and Product Development
· Analytical Chemistry
· Stability Testing
· Formulation Development
· Regulatory Affairs
· Pharmaceutical & Biopharmaceutical Production
· Quality Control and Quality Assurance
· Technical Operations

Course Programme
Day 1
The course will commence at 8.30 with registration and coffee, course proper will commence at 9.00 and finish at 5.00pm each day
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 .