Course Description:
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.
Upon completion of this course, you will be able to:
- 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 standards for control of plastic components related to pharmaceutical manufacturing equipment and USP General Chapters <665> and <1665>
- Discuss the pharmacopeial standards for 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.
Who should participate:
- Analytical R&D
- Pharmaceutical R&D
- Manufacturing Engineering
- Manufacturing Operations
- Regulatory Compliance
- QA/QC
- Packaging Engineering
- Packaging Operations
- Quality Auditing
- Toxicology
The live version of this recording took place on December 14-15, 2021.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
Preview: USP standards related to material screening & characterization of Extractables and Leachables. This is one of many topics disc