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Impurities in APIs and Pharmaceutical Products Current Regulatory Requirements
Impurities in active pharmaceutical ingredients (APIs) and in pharmaceutical products is a main issue reviewed both during the assessment of registration files (CTD) and during GMP inspections. Due to the importance and complexity of stability issues this subject is covered directly and indirectly by many regulatory guidelines. The objective of this course is to provide a comprehensive overview of the...Continue reading
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Issues to be covered
- Classification of impurities
- Characterization of impurities during the drug development process
- Genotoxic impurities
- Heavy metals impurities
- Impurities in Generic Products
- Detailed Review of ICH Impurity Guidelines
- Q3A (R2) Impurities in New Drug Substances
- Q3B (R2) Impurities in New Drug Products
- Q3C (R8) Guideline for Residual Solvents
- Q3D (R2) Guideline for Elemental Impurities
- M7 (R1) Assessment and control of mutagenic impurities in pharmaceuticals
- EMA publications regarding nitrosamine impurities in pharmaceutical products
- Test cases via the Israeli ex-regulator point of view
Who should attend
This course is suitable for any person involved in manufacturing, quality control, quality assurance, regulatory affairs, research and development and any other discipline that interfaces with manufacturing and control of pharmaceutical development or production.
Benefits to the Participants
At the end of this course participants will understand the regulatory basis for impurities control requirements. Participants will be familiar with European and US FDA requirements and expectations.
About The Lecturer
