Zielgruppe

This seminar is aimed at pharma professionals engaged in the evaluation
and qualification of single-use materials in the pharmaceutical production processes, as well as primary packaging materials for drug sustances and
drug products.
The seminar will cover all aspects of this topic starting from relevant guidelines, to considerations for the selection of candidate materials for a given product, how to plan Extractable and Leachable studies, relevant analytical techniques, what to look out for when outsourcing these activities and finally how to evaluate compounds that do migrate into the product.
Relevant case studies presented by experts in the field, will open up the discussion for topics coming from the audience.

Zielsetzung

Compounds migrating into pharmaceutical products, either from single-use materials used during the manufacturing process or during the storage of drug substances or final products from the immediate outer packaging, have been in the spotlight for some time. Since there is no distinct guideline available for extractables and leachables assessments, there are currently best practices for orally inhaled nasal drug products (OINDPs), parenteral and ophthalmic drug products (PODPs) set by the Product Quality Research Institute (PQRI). Furthermore guidance is sought-after in ICH Q3D and M7. Currently there is no binding approach to extractable and leachable assessments and therefore there is some uncertainty but also some degrees of flexibility of how to adopt the available best practices and guidelines mentioned.
The first part of the seminar aims at looking, which guidelines and best practices are available and then presenting case studies by exerts in the field to discuss the strategies available for conducting acceptable E&L-evaluations. Then a manufacturer of single-use devices for the production of biopharma-ceuticals will give a rare insight into the efforts made by the industry to evaluate and control the risk of compounds migrating into to the drug substance. The second part will take a different perspective on the topic, discussing what to do in the unfortunate event a leachable is identified and have a toxicologists view of what information is required to make a valid toxicological assessment.
Finally, we will take a closer view on materials commonly used in parenterals and which risks are involved and how they can be controlled.
By presenting case studies, this seminar wants to offer strategies and ideas how evaluate and qualify materials from primary packaging and single use devices and how to adopt theses for own, future project. Open discussions about the offered strategies may lead to a consensus approach to E&L-studies and to less uncertainty in the community.