Impurities in APIs and Pharmaceutical Products Current Regulatory Requirements

Conducted by: Dr. Rachel Karpel
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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

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 current approaches used to control impurities level in pharmaceuticals.

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Dates: 
  • 09/01/2023
  • 11/01/2023
Course location: Zoom Course
Duration: 1-Day Course
Hours: 10:00 - 14:00
Credits: 1
Course Language: עברית

Course price: ₪1,950 + VAT
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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
  • Other ICH related guidelines
  • EU guidelines
  • FDA guidelines

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

Rachel Karpel
Dr. Rachel Karpel served for 12 years at the Israel Ministry
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