Introduction to Photostability
The purpose of this course is to give an overview of photostability and where it fits in the stability testing programme and the importance of photostability. 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 programme?
- Why does photostability matter? (exercise)
Coffee and registration will be available from 8.30am, 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.
Michael Gamlen (Tableting and Stability Testing Expert)
Michael is managing director of Pharmaceutical Development Services Limited, a Nottingham UK-based technical consultancy. Michael has over 30 years experience of tablet development. Awarded a first class honours degree in pharmacy, specialising in pharmaceutical engineering. He studied for a PhD at Nottingham University. He was head of tablet development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica Limited and as a consultant. He specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional tabletting courses for many years. His courses are highly rated, often exceeding the expectation of participants.
Michael continually updates the content of his courses with guidance and extracts from latest scientific papers. He provides a substantial amount of relevant literature to all course participants and copies of all notes and guidance used. He is very popular presenter.
The course is designed for people working in:
- Analytical Development
- Analytical Chemistry
- Stability Testing
- Technical Operations
- Research and Development Chemistry
- QA/QC
- Formulation Development
- Pharmaceutical & Biopharmaceutical Manufacturing/Production
- Product Development
- Regulatory Affairs
- GLP/GMP Compliance
NULL
