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Nitrosamine Impurities Forum - APAC

07 Sep - 08 Sep 2020   |   Virtual Course


Course Overview

Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens. Although they are also present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable.

The U.S. Food and Drug Administration (USFDA) is investigating several potentially cancer-causing substances, called nitrosamine impurities, recently found in some drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. Some of these drugs from certain manufacturers – including angiotensin II receptor blockers (ARBs), ranitidine, and nizatidine – have been recalled because of the presence of nitrosamine impurities.

In the European Union (EU), following an Article 31 review of sartans at risk of containing nitrosamine impurities (those containing a tetrazole ring), 9 manufacturers were asked to review and make changes to their manufacturing processes to minimize nitrosamine impurities to the extent practically possible. The problem of the presence of nitrosamine impurities has global implications and ramifications for the Indian pharmaceutical industry & possess challenges related to:

Presence of a toxic impurity in API

Presence of a toxic impurity in API

Inadequate risk assessment

Lack of product and process understanding

Stability/storage issue

Benefits of Attending


Understanding the global regulatory norms and recent amendments to mitigate risk due to nitrosamine impurities

Comprehending the recent analytical tools and techniques to address these impurities

Strategizing the right techniques at right stage to eliminate the presence of these impurities in drug substances and drug products

Identifying the various sources and adopting accurate methods to avoid product recall

Who Should Attend?


INDUSTRIES

  • Pharmaceuticals
  • Life Sciences
  • API Manufacturers
  • Bio- Pharmaceuticals

DEPARTMENT

  • Quality Assurance
  • Quality Control
  • R&D
  • Analytical
  • Production & Manufacturing
  • Packaging
  • Regulatory




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