Lifecycle Management of Impurities - From Development to Market
Tuesday | 20 October
Highlights
Practical assistance and experiences how to set specifications for impurities and how to prepare your dossiers accordingly. Get the information from our Speakers about the quality and regulatory perspective of:
- Managing Impurities During Development of Chemical
Processes - How to deal with Impurities in the Dossiers
- Pharmacopoeial Impurity Control
Target Audience
This ECA course is designed for all persons involved in the manufacture of APIs especially for persons from production, development, quality control, quality assurance, technical and regulatory affairs departments. We are also addressing interested parties from the pharmaceutical industry and GMP inspectorates.
Objectives
This ECA course provides an overview of how to do the lifecycle management of impurities – from development to market.
During interactive sessions you will get to know:
- General principles of impurity control
- How to set starting material specifications with limited data available
- How to make the link between impurities and the process
- How to evaluate potential impurities not present in your product
Furthermore, you will have the opportunity to reach clarification on ambiguous issues by bringing your questions up for discussion during the Q&A sessions.
This ECA course ideally complements the following 29th APIC/CEFIC Global GMP & Regulatory API Conference.
Programm
Pharmacopoeial Impurity Control
- General principles of impurity control
- Types of impurities and analytical aspects
- Specification setting
- Special groups: elemental impurities and nitrosamines
How to deal with Impurities in the Dossiers
- Specified impurities
- Potential impurities not present in your product
- Making the link between impurities and the process
- “New” impurities throughout the lifecycle of the product
Managing Impurities During Development of Chemical Processes
- Importance of adequate analytical procedures
- Impurity profile of tox batch: “too pure” vs. “too dirty”
- Finding the right balance: Phase appropriate controls
- Case study: “Setting starting material specifications with limited data available”
Q&A Sessions
Take advantage of the experiences of our speakers and send us your questions and real-life scenarios/challenges prior to the ECA course. Your questions and examples are appreciated and will be answered as comprehensively as possible by the experts during the break-out sessions and Q&A sessions.
Tour of Laboratories and Pilot Plant at NCK A/S, Denmark
This course is complemented by a site tour at NCK A/S (NCK).
It is an independent CDMO specialising in organic synthesis, and providing the pharmaceutical industry with materials for pre-clinical, toxicological and clinical studies. NCK’s facilities include analytical and chemical laboratories as well as two pilot plants with reactor volumes ranging from 40 to 300 L both inspected by the regulatory authorities and GMP approved. Specifically, NCK offers services like development of manufacturing processes for APIs or advanced intermediates, GMP manufacturing of APIs for clinical trials, development and validation of analytical test methods and ICH stability studies.
Bus shuttels will take you to the site and back to the hotel.