Sambhujyoti Das

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Fresenius Kabi India Pvt Ltd
Deputy General Manager of Quality
Sambhujyoti Das is Assistant General Manager of Quality Assurance at Fresenius Kabi Oncology Ltd. He’s responsible for quality- and regulatory compliance–related supports to the company’s manufacturing units in India (Standard Solutions) and South Africa. He has more than 15 years of professional experience in pharmaceutical quality assurance and validation, earned a master’s degree in pharmacy, and is a certifi ed Lean Six Sigma black belt. He has been an ISPE member since 2013.

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Evaluation of Visual Inspection in Parenteral Products

According to US Pharmacopeia (USP) Chapter <790>, “all parenteral products should be essentially free from any visible particles.”1  This is the first and foremost requirement stated in all pharmacopeia for any injectable product. However, yielding absolutely particle-free...

  • 1United States Pharmacopeia. USP Chapter <790>: Visible Particulates in Injections.