Regulatory aspects of Genotoxic impurities

Genotoxicity is defined as a destructive effect on a cell's genetic material (DNA, RNA) affecting its integrity. In most cases, genotoxicity leads to mutations in various cells and other bodily systems. Mutations can lead to a host of other problems, from cancer to a wide variety of different diseases. Thus it is essential to identify, categorize, and control these mutagenic impurities in pharmaceutical products and drug substances. Various regulatory agencies such as ICH, EMEA, USFDA provide guidelines to assess and control genotoxic impurities in drug substances and drug products.

Category: Crash Courses
Duration : Training duration: 75 minutes, course would be accessible for 1 month from the date of admission

Learning objectives

It covers the following topics.

  • Impurities assessment
  • Hazard assessment
  • Risk characterization 
  • Control strategy 
  • Documentation


B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.

Anyone willing to know this topic can enroll.


  • Section 1: Genotoxic impurities 75 minutes
    • Genotoxic impurities 75 minutes

Fees : 1700

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    Course Include :
  • Video
  • PDF