How to evaluate potential risk factors associated with leaching substances
How to design extractables studies as part of material qualification and selection
How to control and manage the life cycle of E&Ls
How to assess the toxicological risks of E&Ls
You will also get an update on requirements and expectations of E&L testing and risk management from a regulatory perspective.
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 specific kind of extractable/leachable 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. Therefore, the ICH is currently working on a new ICH Q3E Guideline for Extractables and Leachables (E&Ls) to “assist both applicants and regulators by providing focus on critical aspects, and improving transparency in requirements for medicinal products including drug delivery device components”.
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. Recently, particular attention was paid to devices and equipment used in the production process, e.g. filters, bags, tubes.
Target Group
The course is designed for personnel of pharmaceutical companies and their suppliers who
are responsible for setting up E&L studies and E&L testing.
work in quality control of packaging materials.
specify and select polymeric, glass and rubber materials, devices and Single Use Equipment in process development and manufacturing.
develop material sourcing strategies.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Analytical methods, target analysis or screening or both
Analytical sensitivity adjustment, correlation with analytical evaluation threshold
Impact of sterilization methods on materials chemical composition
Strategies for Complex Formulated Drug Products
Analytical method requirements, validation of Leachables analytical Methods
Development of Leachables strategies based on Extractable profile and toxicological report
How to deal with trustable and poorly characterized chemical profiles
How to establish the “chemical link” between Extractables & Leachables
Leachables observed only in Leachables study but not in the Extractables Study: What to do?
OOS case
Analytical Challenges and Solutions for Extractables & Leachables
Essential Analytical Expectations for E&L Studies
Qualitative Aspects of Extractables and Leachables
Identification and Good Identification Practices
Quantitative Aspects of Extractables and Leachables
Analytical Uncertainty
When to Quantify –The Analytical Evaluation Threshold (AET)
How to Quantify –Good Quantitation Practices
Q&A Session 2
Day 2
Elastomeric Closures in E&L Assessment
Composition of Elastomers used for Pharmaceutical Applications
Discussion Material Composition and Extractables (Potential Extractable List)
Approaches to minimize Extractables/ Leachables from Elastomeric Closures
Case Study presentation
Practical Examples for E&L Testing in Medical Devices
Key aspects of ISO 10993-1 and ISO 10993-18 for E&L testing of medical devices
General procedures, challenges, and pitfalls
Case studies and practical examples
Toxicological Assessment of E&Ls in Medical Devices
Key aspects of ISO 10993-17 for the toxicological Evaluation
General procedures, challenges, and pitfalls
Case Studies for different assessment procedures
Q&A Session 3
Control and Life Cycle Management of E&Ls
Batch-to-batch consistency in composition and purity of packaging components
Acceptance criteria for Extractables/Leachables
Quality agreements with suppliers
Change Management
E&Ls for SUS as Elements of Process Qualification/Validation and Safety Assessment
Single-Use process equipment (e.g. filters, bags)
Risk-based evaluation and testing strategies
Influence of leachables on: - biopharmaceutical process Performance - the stability of biopharmaceuticals - the analytics of biopharmaceuticals
Simplified E&L Assessment using prior Knowledge and IT Solutions
Prediction of extractables profiles for SUS of different sizes and complex assemblies
Calculation of exposure data, with a subsequent automated safety-assessment; including a discussion of deviations and propagation of deviations
Equivalence study of extractables profiles from an SU assembly before and after a component change, including the evaluation of the impact on the safety assessment
Using the system to extrapolate extractables data to USP <665> conditions for a safety assessment of a large volume injectable drug product
Q&A Session 4
This course is part of the GMP Certification Programme "ECA Certified Packaging Manager" Learn more
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Seminar Programme as PDF