European Inspectors Spot GMP Deficiencies In India During ‘Virtual Tours’
It Almost Felt Like We Were There, Says EDQM Inspector
A senior inspector at the European Directorate for the Quality of Medicines & HealthCare explained how some “out-of-the-box thinking” was leading to a new approach for inspecting companies.
You may also be interested in...
Dr Reddy's On Digitization Amid COVID-19, 'Lights-Out' Manufacturing
Dr Reddy’s global head of quality outlines how the company leveraged digitization to keep plants running at full throttle amid the pandemic and went on to operationalize a site for remdesivir designed as a "lights out" facility. Certain facilities at the Indian firm have also undergone remote inspections by major regulatory agencies.
ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient
The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.
EMA Looks For Efficiencies For Companies Ahead Of Relaunching Clinical Data Transparency Policy
Based on its learnings from proactively publishing clinical trial data on COVID-19 products, the European Medicines Agency is making procedural changes to its clinical data publication policy that is set to resume after being temporarily suspended in 2018.