Live Online Training "Leachables & Extractables" - Current Regulatory and Scientific Developments
Im Auftrag der ECA Academy

2 July 2020

Seminar Nr. 18186

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Armin Hauk, Sartorius Stedim Biotech GmbH
Dr Andreas Nixdorf, SGS Institut Fresenius GmbH
Gaby Reckzügel, Boehringer Ingelheim Pharma GmbH & Co. KG

Zielsetzung

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 factors associated with leaching substances 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 also 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 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.

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

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,
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

08.30 – 08.40 h
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

09.40 – 10.40 h
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

10.40 – 11.00 h Break

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

14.00 – 15.00 h
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

15.00 – 15.15 h Break

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

16.00 – 16.30 h
Q&A Session 2

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Live Online Training "Leachables & Extractables" - Current Regulatory and Scientific DevelopmentsIm Auftrag der ECA Academy