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>, <476>, and <1086>; FDA and ICH Guidance on impurities and will use case studies to further underscore proper application themes.
Subject area:
Drug Products & APIs
Objectives (If applicable):
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:
Discuss the origin and classification of impurities in pharmaceuticals.
Explain global guidance’s for impurities.
Describe the USP approach to impurities in drug substances and drug products.
Discuss the USP general chapters on impurities.
Explain the USP approach to harmonization across pharmacopeia.
Demonstrate knowledge of USP’s approach for impurities in documentary standards via case studies.
Target Audience (If applicable):
QC/QA personnel and management, regulatory compliance personnel and management, analytical scientist and workbench chemists responsible for quality assessments, regulatory agencies