If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: firstname.lastname@example.org
Dr Armin Hauk, Intertek, Switzerland
Petra Motzkau, Sartorius Stedim Biotech
Dr Andreas Nixdorf, SGS Institut Fresenius
Dr Ralph Nussbaum, Analytical Services
Gaby Reckzügel, Boehringer Ingelheim Pharma
Dr Mike Schäfers, West Pharmaceutical Services
Karl-Heinz Schneider, CSL Behring GmbH
Dr Jörg Zürcher, Bayer Schering Pharma
Over the last years, the requirements on the assessment of substances that could leach into the drug product in the course of its life cycle have increased considerably.
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 already at a very early stage in process development.
Packaging materials have been in the focus of such investigations for a long time as the contact time between drug product and packaging material is rather long.
But in addition you have to consider other possible sources of contamination. Recently, particular attention was paid to devices and equipment used in the production process itself, e.g. filters, bags, tubes. The trend towards single-use equipment might relieve the pressure on cleaning validation. At the same time leachables/
extractables testing will become a topic of major concern.
Within the scope of this GMP Education Course, all relevant aspects of FDA/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.
The course is designed for personnel of pharmaceutical companies and their suppliers who
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.
Introduction to Plastics
Physical and chemical characteristics
Different types of additives in plastics
Regulatory Requirements for Extractables / Leachables Testing
Why should Extractables & Leachables be assessed?
Regulatory requirements of EMA and US-FDA
Compendial requirements and foodstuff regulations
PQRI and other recommendations for Safety Thresholds and Best Practices for Extractables & Leachables testing
Extractables and Leachables Testing in Packaging Material
Why – Regulatory requirements of FDA and EMEA
What – Change in primary and secondary packaging material or labels
How – Global and tailored approaches
Annual Guest Presentation: Challenges in L&E Testing
Sample preparation – How to avoid pitfalls
Analytical methods – How to increase analytical performance
Leachable testing – Method validation approach
Routine Extractables Testing in Quality Control
Batch-to-batch consistency in composition and purity of packaging components
Acceptance criteria for extractables profiles
Quality agreements with suppliers
Plastic-Derived Materials for the Manufacture of Biopharmaceuticals
Drug Product Perspective
Plastic Materials: Selection and Characterization
Extractables & Leachables: A Pragmatic Approach
In-Process Materials with Product Contact
Elastomeric Drug Product Stoppers
Experience with Regulatory Agencies
L&E Strategies in Practice
How to design a reasonable E&L study („to do enough but not too much“)
The translation of regulatory requirements into analytical lab work
The evaluation of extractables data and
consequences to leachables studies
How to outsource E&L studies
Extractables from Glass
Type of extractables from glass
Risk evaluation of glass extractables
Concepts to avoid extractables from glass
Extractables from Elastomers – Parenteral Packaging Testing Composition of Elastomers used for Pharmaceutical Applications
Discussion Material Composition and Extractables (Potential Extractable List)
Approaches to minimize Extractable/ Leachable from Elastomeric Closures
General Approach to Extractable/ Leachable Studies for Parenterals
Leachables during Manufacturing
Bag-filter-assemblies and other polymer-based
materials in the manufacturing process
Finding the right test approach under consideration of critical success factors for the pharma/biotech industry such as cost efficiency, time-to-market and regulatory compliance
Model solvent testing versus product and process specific testing
Evaluation of the test results
Printing Inks as Potential Sources of Extractables & Leachables
Introduction and basics of printing techniques
Composition & chemistry of ink systems (“the ink manufacturer’s toolbox”)
Possible interactions of printing ink systems with the packaging material and the drug formulation
Illustrative examples of extractables from printing
Relevance of ink components as leachables.
In the course of this workshop you will develop a strategy for conducting a compliant and reasonable leachables study. The task will be based on an industry example. It will be your challenge to answer the following questions:
Which activities are necessary during the development phase?
How will you deal with quality control during routine production?
Where will you find useful information about the material you are going to use?