Puneet Sharma

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GSK Consumer Heath
Principal Scientist
Puneet Sharma has a master’s degree in pharmaceutical sciences from the University of Delhi. He has been part of GSK’s Manufacturing Science and Technology (MS&T) organization since 2015 as a Product Lifecycle Science Lead. In his role, Puneet is responsible for managing complex product and process remediation issues by utilizing the concept of quality risk management tools, QbD principles, and the DoE framework. Before his MS&T role, he worked in research and development for 15 years developing NDA, ANDA, and novel drug delivery systems. His research interests include formulation and process design, novel drug delivery systems, and process analytical technology in the small molecule research field. Puneet has been an ISPE member since 2019.

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Figure 1: Macro operation flowchart.
Technical
Automating MACO Calculations in Cleaning Validation

For a multiproduct facility where equipment is shared, there is always a risk from cross-contamination. The correct calculation of the cleaning validation limits from maximum allowable carryover (MACO) of a marker compound to the next product is vital for the integrity and success of the cleaning validation program. However, the process yielding those limits often involves cumbersome,...