The potential for harmful chemicals to be extracted from packaging materials and pose a risk to patients has spurred regulatory authorities to establish guidelines for extractable and leachable testing for primary drug packaging materials. Drug license holders must establish programs that effectively assess and test these contamination risks.
In this webcast, participants will learn about the regulatory requirements for extractables and leachables in primary packaging and the importance of risk assessment for different drug dosage forms and types of materials. Regulations and guidance documents from the FDA and European Medicines Agency will be reviewed, as well as ICH guidelines for pharmaceutical development and quality risk management. In addition, compendial requirements from the US Pharmacopeia and the European Pharmacopoeia for glass and plastic packaging, safety impact, and extractables and leachables testing will be examined. Best practices for extractables and leachables testing will be shared.
Key Learning Objectives
- Understand the regulatory requirements for different drug dosage forms and packaging materials
- Learn best practices for extractables and leachables testing programs
- Understand the steps involved in extractables testing and safety thresholds
For more information, please contact:
Life Sciences Marketing Manager
t: +1 877 677 2667