Introduction to Photostability

Overview

The course is highly interactive and held in a relaxed environment.

It will cover:

• Why do we do photostability tests?
• Concepts and background in photostability
• Identifying drug substances most likely to absorb light and display signs of poor photostability
• Understanding photostability terminology
• Where does photostability fit in the overall stability testing program?
• Why does photostability matter? (exercise)

Course Programme
Coffee and registration will be available from 8.30am on Wednesday 30th June, course proper will commence at 9.00am. We anticipate the course will finish at 5.00pm..

Formulating and manufacturing unstable products

• Formulation development and evaluation for photolabile materials
• Protection during the manufacturing process
• Getting the product to the patient

ICH guidelines for photostability testing: Using ICH Q1B guidance in practice

• Understanding the terms and procedures used in the guideline

Practicalities

• Light source selection - Options 1 and 2
• Sample presentation
• Humidity and temperature control
• Selecting sample containers

Forced degradation: Practical and regulatory aspects of photostability stress testing

• Selecting experimental conditions for stressing samples with respect to light

Meeting regulatory requirements

• Documentation – principles and practice
• Stability testing and the Quality System
• SOPs for stability testing
• Equipment validation and calibration – do the chambers work?
• Protocol development and approval

Reporting stability test data

Delegate Workshop
Problems and issues for discussion

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.