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2007 Leachables and Extractables Workshop Documents |
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Training Course AgendaBest Practices for OINDP Pharmaceutical Development Programs Leachables and ExtractablesApril 12-13, 2007
Chicago, IL
Thursday, April 12, 2007
8:30 am
Light Breakfast
9:00 am
Session I: Introduction and Overview
Presenter:
Dan Norwood, Ph.D.
Boehringer Ingelheim Pharmaceuticals
- Introduction of training course faculty
- What are leachables and extractables?
- Significance of leachables and extractables to OINDP pharmaceutical development programs, i.e., do you want an approval or not?
- Overview of pharmaceutical development process
- Quality by Design concepts (QbD)
- Overview of training course
- Feedback from trainees regarding course outline and content
9:30 am
Session II: OINDP Container Closure Systems
Presenters:
Michael Ruberto, Ph.D.
NAFTA, Ciba Chemicals
Doug Ball
Pfizer, Inc.
- Container closure systems components and their selection - QbD
- Container closure system suppliers
- Evaluation of information available from suppliers
- Early safety assessment of potential leachables – case studies and interaction of analytical chemists and toxicologists
10:30 am
Break and Open Discussion
10:45 am
Session III: Safety Evaluation of Extractables and Leachables
Presenters:
Doug Ball
Pfizer, Inc.
Tom Feinberg, Ph.D.
Cardinal Health
- Overview
- Safety thresholds for leachables
- Extension of safety thresholds to extractables
- The Analytical Evaluation Threshold (AET)
12:15 pm – 1:00 pm
Lunch
1:00 pm
Session IV: Analysis of Leachables and Extractables
Presenter:
Dan Norwood, Ph.D.
Boehringer Ingelheim Pharmaceuticals
- Principles of trace organic analysis
- Analytical techniques for identification of extractables and leachables
- What does it mean to “identify” an extractable or leachable?
- Identification criteria for extractables and leachables
- Quantitation of extractables and leachables
2:00 pm
Session V: Characterization of Extractables
Presenter:
Diane Paskiet
West Monarch Analytical Laboratories
- The Controlled Extraction Study
- Application of the AET for extractables
- Evaluation of Controlled Extraction Study results
4:00 pm
Break and Open Discussion
4:15 pm
Session VI: Special Case Compound Classes
Presenter:
James Mullis
Boehringer Ingelheim Pharmaceuticals
- Nitrosamines – origins, analysis and control
- Polynuclear Aromatic Hydrocarbons (PAHs or PNAs) – origins, analysis and control
- 2-Mercaptobenzothiazole – origins, analysis and control
Friday, April 13, 2007
8:00 am
Light Breakfast
8:30 am
Session VII: Characterization of Leachables
Presenter:
Tom Feinberg
Cardinal Health
- Analytical method development for leachables
- Validation of analytical methods for leachables
- Application of the AET for leachables
- Leachables testing on formal stability programs
- Correlation of leachables and extractables
10:00 am
Break
10:15 am
Session VIII: Quality Control and Specification Setting
Presenter:
Terry Tougas, Ph.D.
Boehringer Ingelheim Pharmaceuticals
- Control of leachables through control of extractables
- Analytical methods for routine quality control of extractables
- Validation of analytical methods for routine quality control of extractables
- Establishing extractables specifications and acceptance criteria (process capability analysis, statistical approaches)
- Establishing leachables specifications and acceptance criteria (process capability analysis, statistical approaches)
11:45 am
Panel Discussion/Q&A - QbD
All Faculty and Attendees
12:30 pm
Lunch
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