This course focuses on extractables and leachable(E&L) as it relates to the interaction between drug products and their various contact surfaces. Applicable USP chapters, packaging systems, pharmaceutical process equipment and regulatory concerns will also be addressed along with current best practices regarding the quality and selection of packaging material and testing for extractables and leachables.
Subject area:
Drug Products & APIs
Objectives (If applicable):
– Define E&L terms and concepts
– Explain the importance of timing of E&L studies and quality selection of packaging materials.
– Describe quality control of packaging materials throughout the supply chain
– Summarize the pharmacopeial control of plastic components related to pharmaceutical manufacturing equipment and USP General Chapters <665> and <1665>
– Discuss the pharmacopeial control of glass, plastic, and elastomeric packaging materials as it relates to USP General Chapters <381>, <660>, <661>, <1660>, and <1661>
– Explain the importance of USP General Chapters <1663> Principles of Extractable Assessment and <1664> Principles of Leachable Assessment
– Identify the origins of E&L—material selection and early assessment
– Explain the range of extraction conditions
– Discuss the evaluation of organic and inorganic extractables
– Describe the safety assessment of extractables
– Explain the evaluation of leachables
Target Audience (If applicable):
• Analytical R&D
• Manufacturing Engineering
• Packaging Engineering
• Packaging Operations
• Pharmaceutical R&D
• Regulatory Compliance
• QA/QC
• Quality Auditing
• Toxicology