Sprecher
Dr Andreas Nixdorf, SGS Institut Fresenius GmbH
Gaby Reckzügel, Boehringer Ingelheim Pharma GmbH & Co. KG
Zielsetzung
The kind of leachable you would have to look for can vary from organic oligomers and catalyst residues to heavy metals – to name a few. Due to the resulting complexity, it is very important to consider the potential risk factors associated with leaching substances already at a very early stage in process development
Within the scope of this GMP Education Course, all relevant aspects of Pharmacopoeia/GMP - compliant leachables and extractables testing will be addressed ranging from regulatory requirements to routine extractables testing in quality control.
Experienced industry speakers share their in-depth knowledge with you.
Zielgruppe
- are responsible for qualification of extractables/leachables in quality control,
- perform leachables/extractables testing,
- work in quality control of packaging materials,
- choose and define polymeric, glass and rubber materials in process development,
- choose and define Single Use Equipment for manufacturing,
- develop materials sourcing strategies.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Introduction
08.40 – 09.40 h
Extractables & Leachables: Regulatory and Scientific Perspectives
- What are Extractables and Leachables?
- Regulatory requirements of EMA and US-FDA
- Compendial requirements
- Scientific aspects
Best Practices for Controlled Extraction Studies
- PQRI recommendations for Extractables studies
- USP <1663> Assessment of Extractables from pharmaceutical packaging systems
- PQRI recommendations and ICH Guidelines: Safety thresholds and Permitted Daily Exposure
11.00 – 12.00 h
Q&A Session 1
12.00 – 13.00 h Break
13.00 – 14.00 h
Leachable Studies Design Strategy in Complex Formulated Drugs
- Establishment of Leachables Strategies, the Design Space
- Extractables & Leachables Correlation
- Non-targeted Screening vice versa Validated Target Analysis
- Drug Matrices: Impacts on Leachables Discovery and Identification
- The Large Volume Problem, Analytical Uncertainty, Design Space Solutions
- The Leachables Shelf Life Program
E&L for Single Use Systems as Elements of Process Qualification/Validation and Safety Assessment - Part 1
- Introduction on Single Use Systems (SUS/SUT)
- The Need for E&L Data for SUS in biopharmaceutical processes
- E&L Data for SUS as elements of the qualification triangle
- The concerns with E&L regarding process performance, product quality and patient safety
15.15 – 16.00 h
E&L for Single Use Systems as Elements of Process Qualification/Validation and Safety Assessment - Part 2
- Extractables vs. simulation studies for SUS
- Requirements on E&L Data to be suitable for a risk assessment
- The need for extrapolation of SUS extractables data towards process equipment related leachables (PERLs) and towards process conditions
- Modelling approaches as mitigation concepts in the SUS area
Q&A Session 2
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Seminarprogramm als PDF
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