Mr. Muhammad Naeem, Managing Director

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Pharmatec Pakistan Private Limited
MS, USA, RAC (RAPS, USA)
Muhammad Naeem has more than 23 years of diversified experience in Business Development, Marketing & Sales. Quality Operations, Regulatory Affairs, Research and Development, and Operational Excellence. Currently, he is Managing Director at Pharmatec Pakistan Pvt. Limited. Muhammad has RAC-Global certification from Regulatory Affairs Professionals Society (RAPS) and is an active member of ISPE, the Parenteral Drug Association, and RAPS, USA. He has extensive working knowledge of global pharmaceutical regulations and has led investigational/developmental and technical/analytical projects at contract manufacturing organizations in the US, Europe, and Pakistan. Muhammad has presented on QRM, data integrity, pharmacovigilance, QMS elements, validation, and cGMP guidelines at national and international conferences. He has been an ISPE member since 2015.

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Figure 1: Example of fishbone analysis as a tool for risk identification.
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Quality Risk Management to Address Product Impurities

Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine (NDMA) impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout the product life cycle to ensure patient safety.1