The course will address the increased regulatory concerns regarding extractables and leachables related to the interaction of drug products with various drug product contact surfaces—including packaging systems and pharmaceutical process equipment. Learn how to apply current best practices related to the quality and selection of packaging material and testing for extractables and leachables.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Discuss the definitions and concepts for E&L
– Understand the importance and timing of E&L studies
– Understand the quality and selection of packaging materials—importance with reference to E&L
– Explain the quality control or packaging materials throughout the supply chain
– Explain the pharmacopeial control of glass, plastic, and elastomeric packaging materials: USP General Chapters <381>, <660>, <661>, <1660>, and <1661>
– Understand the USP Chapters <1663> Principles of Extractable Assessment and <1664> Principles of Leachable Assessment
– Determine the origins of extractables & leachables—material selection and early assessment
– Explain the range of extraction conditions
– Discuss the evaluation of organic and inorganic extractables
– Understand the safety assessment of extractables
– Discuss the evaluation of leachables

Target Audience (If applicable):
– Analytical R&D
– Packaging engineering
– Packaging operations
– Pharmaceutical R&D
– Regulatory compliance
– QA/QC
– Quality auditing
– Toxicology