K Bangarurajan | Deputy Drugs Controller West Zone
CDSCO | India

K Bangarurajan, Deputy Drugs Controller West Zone, CDSCO


Conference Day 2 @ 14:10

Ensuring uniformity of GMP inspections in biologics manufacturing

Biologics Manufacturing
Countries across the globe are concerned about the safety and efficacy of the drugs supplied. As India expands its biologics supply globally, there is an increased emphasis in ensuring uniformity in inspection requirements for drugs manufactured in India. This panel discusses how global regulators such as US FDA, EMA can work closer together with CDSCO in ensuring uniformity in GMP inspections.
  • Overview of India’s inspection landscape and updates
  • Understanding the differences and overlaps in current standards
  • Exploring ways for various regulators to work closer together, including more combined inspections for newly recruited CDSCO inspectors
Mayur Parmar, Senior Drug Inspector, Gujarat FDA
K Bangarurajan, Deputy Drugs Controller West Zone, CDSCO

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