Regulatory aspects of Nitrosamine impurities

Nitrosamine impurities became a focus for authorities in July 2018, when they announced a recall of angiotensin II receptor blocker (ARB) medicines, known as “sartans”, due to the presence of an impurity, N-nitrosodimethylamine (NDMA). The source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. Nitrosamines are classified by the ICH M7(R1) Guideline as Class 1 impurities, “known mutagenic carcinogens,” Thus, addressing these impurities in drug substances and drug products has become of utmost importance from a regulatory perspective.

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

Learning objectives

This lecture covers sources of nitrosamine impurities,  risk management study and their controls.
The chemistry aspects of nitrosamines are illustrated. It also discusses case studies which help to understand the use of risk management strategy in practice

Eligibility

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].

Anyone willing to know this topic can enroll.

Syllabus

  • Section 1: Nitrosamines impurities
    • Nitrosamines impurities 75 minutes

Fees : 2124

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    Course Include :
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