Extractables & Leachables - Part 2 (10691)

Course details

Course Extractables & Leachables - Part 2
Trainer Dr. Helmut Buschmann
RD&C Research, Development & Consulting GmbH

Dr. Norbert Handler
RD&C Research, Development & Consulting GmbH
Period 12/06/24
State scheduled
Category Webinar
Language English
Free places
Fee €395.00 plus VAT.
Book for myself Book for group

Over the last years, the requirements for the assessment of substances that could leach into the drug substance and drug product in the course of its life cycle have increased considerably.

The specific kinds of extractables/leachables can vary from organic oligomers and catalyst residues to heavy metals – to name only 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&L) 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 substance or drug product and packaging material is rather long. But, in addition, other possible sources of contamination also have to be considered. Recently, particular attention has been paid to devices and equipment used in the production process itself, e.g. filters, bags and tubes. The trend towards single-use equipment might relieve the pressure on cleaning validation and the need to introduce control strategies along the supply chain to avoid unintentional added impurities in materials. At the same time leachables/extractables testing will become a topic of major concern.

This webinar will present the latest developments and the current status of regulatory compliant E&L assessments and cover the following aspects:

  • Designing extractable studies
    • Extractable 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
    • Impacts of sterilisation methods on the chemical composition of materials
  • Analytical techniques to be used
    • Analytical method requirements, validation of analytical methods for leachables
    • Method development for leachables and validation 
    • Analytical evaluation threshold (AET)
  • Safety assessments/toxicological thresholds
    • Control strategy options
    • PQRI recommendations and ICH Guidelines: Safety Thresholds and Permitted Daily Exposure
    • Available data bases and other scientific sources
    • Development of strategies for leachables based on extractable profile and toxicological report
    • How to deal with trustable and poorly characterised chemical profiles
    • How to establish the “chemical link” between extractables & leachables
    • Explanation of differences in the toxicological evaluation of substances for medicinal products and other regulatory fields like medical devices  
  • Interpretation and use of extractables data; from extractables data to potential exposure estimations
    • Physico-chemical principles of extraction versus extractables protocols
    • Use of extractables data in scaling and combination exercises
    • Use of extractables data in exposure estimations
    • Differences in data interpretation for CCS and SUS
    • Quantitative mitigation concepts for the assessment of SUS

Duration: approx. 120 minutes
Language: English | Handout: English

...more from your speaker Dr. Helmut Buschmann...
...more from your speaker Dr. Norbert Handler...

Webinars allow you to conveniently attend training sessions and technical presentations from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

The modules in this series can also be booked individually. You can find them in our course calendar.

Note on contingent call-off: When booking this single part described here, one part per participant will be deducted.

For whole teams we offer attractive special prices with special advantages or develop your own in-house training for you - please contact us.

Course times

Weekday Time
Wednesday 10:00 - 12:00


Virtual online event via GotoWebinar

Powered by SEMCO®