Dr Armin Hauk
Sartorius Stedim Biotech
Referent:innen
Dr. Katrin Buss
Quality Assessor
Dr Ana Kuschel
West Pharmaceutical Services
All times mentioned are CEST.
Zielsetzung
In this Live Online Training you will learn
- 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”.
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.
Zielgruppe
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.
Programm
Gesamtes Programm als PDF herunterladen
Day 1
Introduction to Plastics used in Medical Applications
- Classification of Plastics
- Physical and chemical characteristics
- Different types of additives in plastics
Regulatory Perspective (Authority View)
- Applicable Guidelines (EU)
- Update on ICH Q3E
- Experiences in regulatory submissions
Regulatory and Scientific Perspective (Industry View)
- Regulatory requirements of EMA and US-FDA
- Compendial requirements and foodstuff regulations
- PQRI recommendations and ICH Guidelines: Safety Thresholds and Permitted Daily Exposure
- USP <1663>, <1664>: Best Practices for E&L testing
- Scientific Aspects
Q&A Session 1
How to Prepare a Successful E&L Study
- E&L Study organization for finished packaging’s, timely planning
- Extractables study designs as part of material qualification and selection
- Selection of extraction conditions and methods
- Identification categories, trustable identification
- Semi-quantitation, analytical uncertainty
- 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
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This course is part of the GMP Certification Programme "ECA Certified Packaging Manager"
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