Impurity profile of an active pharmaceutical agent is a topic of interest for both API as well as dosage manufacturers. The expectations of global regulatory agencies is becoming more and more stringent and the manufacturers are expected to control all impurities in the APIs within specified limits based on scientific justification. This webinar will discuss a comprehensive approach to identify potential impurities based on the manufacturing process and determine actual levels of impurities using a validated analytical method.
Regulators are increasingly concerned about presence of genotoxic impurities coming from various sources in the manufacturing scheme and stringent limits are being specified. The discussions will be based on guidance documents ICH Q3b for regular impurities and ICH M7 for genotoxic impurities. Comprehensive strategies for control of such impurities will be discussed.
Areas Covered in the Session :
- Evaluation of potential impurities in APIs
- Guidance on Impurities in drug substances (ICH Q3b)
- Potential degradants
- Determination of impurities in drug substances
- Fixing limits for impurities
- Identification of genotoxic impurities (ICH M7)
- Control of genotoxic impurities
Who Should Attend:
- Research and Development Departments
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Departments
- Manufacturing Departments