Impurities in Drug substance [ICH Q3A]

Impurity is a component of a drug substance that is not the chemical entity defined as the drug substance. Trace amounts of impurities affect the quality, safety and efficacy of the medicine. Therefore, it is very crucial to identify, monitor and control the levels of impurities. Here understanding of manufacturing process, chemistry and regulatory science plays an important role.

Category: Crash Courses
Duration : Training duration: 2 hours 10 minutes, course would be accessible for 1 month from the date of admission

Learning objectives

This course covers related definitions with images, calculations of limits, classification of impurities with example, How to include them in the specification, regulatory requirements  and presentation in drug master file


M.Sc/B.Sc/B.Pharm/M.Pharm/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 understand this topic can enroll.


  • Section 1: Definitions, Classification, Threshold, Case study 130 minutes
    • Qualification, Analytical procedures, Reporting, Listing in specifications, Addressing impurities in regulatory submissions 130 minutes

Fees : 1700

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    Course Include :
  • Video
  • PDF