ZOOM Online: QbD and Lifecycle Management of Analytical Methods
The course aims to give participants a thorough grounding in the principles of Quality by Design and lifecycle management as they apply to analytical methods. It draws on the draft guidance for analytical lifecycle management in ICH Q12, but also the more general guidance on pharmaceutical development, risk management and quality systems contained in ICH Q8, Q9 and Q10.
The course:
- Compares traditional and QbD/lifecycle approaches
- Shows how to apply QbD and lifecycle approaches to the development, qualification and transfer of analytical methods
- Discusses ways of controlling analytical method variability
- Shows how to save effort through the application of a risk-based approach to analytical method lifecycle management
The course material includes slides, handouts and case studies. Attendees will also participate in group workshops and practical exercises and will be encouraged to ask questions throughout the course.
Day 1
8.45 am Registration and Coffee
9.00am –
Regulatory Guidance
- Analytical methods in context – drug safety and efficacy
- ICH guidances Q2, Q8, Q9 and Q10
- ICH Q12 (draft) – lifecycle management
- ICH, US FDA, WHO and PDA method validation guidelines
- Lessons from recent regulatory enforcement letters
Discussion:
problems with the current regulatory approach
10.30 Break
10.45 –
The 2015 US FDA method validation guidance
- Scope and status
- Recommendations for lifecycle management
- The application of quality risk management, design of experiments, ongoing performance verification and knowledge management to method lifecycle management
- Equipment qualification
- Trending method performance
Exercise:
evaluating ongoing method performance
12.30 Lunch
13.30 –
The lifecycle approach
- Advantages
- Application to design, development, validation and ongoing verification of analytical methods
- Lifecycle management and QbD: comparison
- Regulatory status
- Method transfer and compendial method verification
Discussion:
experience with method transfer – risk evaluation
- Importance of risk management
14.45 Break
15.00 –
Rational approach to method development
Discussion:
current approach to method development
Workshop:
what do we need our method to do
- When is method development finished
- Regulatory expectations for HPLC method performance
16:30 End of Day 1
Day 2
9.00 –
The analytical target profile
- Definition
- Comparison with current approach
- Advantages and limitations
- Measurement uncertainty and the method uncertainty budget
Workshop:
writing an ATP based on product specifications
10.30 Break
10.45 –
Risk control in analytical method documentation
- Common problems with analytical method documentation
- Regulatory expectations: contents of analytical methods
- A risk-based approach to analytical method documentation
- Change management during method development
Exercise:
identifying risks in documented analytical methods
12.30 Lunch
13.30 –
Method validation
- Method validation SOP
- ICH Q2 requirements
- Typical validation experiments
- Method robustness: what and how much
- Design of experiments for method robustness
- Statistical tools for results evaluation
- Acceptance criteria examples
Exercise:
setting method validation acceptance criteria
14.45 – Break
15.00 –
Ongoing performance verification
- Aims of ongoing performance monitoring
- Using system suitability results
- Control charts
- Method changes and permitted adjustments
- When to revalidate
- Trending OOS and OOT results
- Continuous improvement
Discussion:
barriers to implementing a lifecycle approach
16:30 End of course
Mark Powell - Analytical Services (Dissolution Testing, QbD, HPLC)
Mark is a Fellow of the Royal Society of Chemistry with over thirty years' experience as a senior analytical chemist. He taught pharmaceutical analysis at the Liverpool John Moores University School of Pharmacy and Chemistry from 1997 to 2003 and was also active in research.
In 2003, he joined the newly-formed Quay Pharmaceuticals, a contract research and manufacturing organisation specialising in early-stage drug development, where he was responsible
for analytical development. Since 2010, as Quay"s Scientific Manager, Mark was involved more generally with drug development programmes and also established collaborations with a number of UK universities and instrument manufacturers. His work at Quay has resulted in a number of published papers and presentations at scientific conferences.
In 2013 Mark set up his own consultancy company and has since worked
for clients all over the world on both early-stage and late-stage drug
development projects. He has particular expertise in dissolution method development and chromatography, and is in demand as a trainer in topics ranging from pharmaceutical analysis to data integrity and technical report writing.
This two-day course is valuable for managers, supervisors and laboratory analysts involved in the development, validation, transfer, verification or amendment of analytical methods in the pharmaceutical industry, including the following functions:
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Contract Analysis
- Analytical Development
