USP Certificate on Impurities
The USP Certificate on Impurities provides prospects with a comprehensive understanding on USP’s risk-based approach to impurity standards and their correlation to International Council of Harmonization (ICH) and Food and Drug Administration (FDA) guidance. Composed of two courses “Impurities in Drug Substances and Drug Products—A USP Approach” and “Analysis of Elemental Impurities”, the certificate will prepare you to evaluate and manage impurities in drug substances and drug products, drug products methods and understand how limits apply to products. Students will also address the evaluation of contaminants, adulterants and foreign substances.
The certificate will cover USP–NF General Chapters <232>, <233>, <466>, <467> and <1086>; FDA and ICH Guidance on impurities and will use case studies to further underscore proper application themes.
There will be a knowledge assessment at the end of each course in this certificate. You will be required to pass this knowledge assessment with a score of 80 percent to determine if your comprehension of the topics presented meets USP’s minimum requirements.
Upon completion of the USP Certificate on Impurities, you will be able to:
Analysis of Elemental Impurities:
- Explain the scope and changes in the requirements of USP–NF General Chapters <232> and <233>
- Describe the risk-based approach
- Explain how to set appropriate specifications
- Describe accuracy and precision: limit tests vs. quantitative impurity tests
- Identify the appropriate instruments for testing (e.g. ICP-OES, ICP-MS, XRF or GFAA)
- Describe proper sample preparation
- Discuss, plan and implement a successful method validation
Impurities in Drug Substances and Drug Products—A USP Approach:
- Describe and apply ICH Guidance Q3A, Q3B and Q3C
- Evaluate contaminants, adulterants, foreign substances and impurities in drug substances and drug products
- Understand extractables and leachables
Target Audience
QC/QA personnel and management, regulatory compliance personnel and management, analytical scientist and workbench chemists responsible for quality assessments, regulatory agencies
Access Duration:Access to this course expires 2 months 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 u