7-8 July | Kathmandu, Bagmati province – The Department of Drug Administration (DDA), Ministry of Health and Population, conducted a two-day training workshop on deficiency categorization of Good Manufacturing Practice (GMP) inspections and audits, with support from WHO Country Office for Nepal. Over 30 officials from the DDA and National Medicines Laboratory, involved in medicine regulation, were trained on skills and competencies in monitoring pharmaceutical manufacturers, using a risk-based approach, to harmonize regulatory work and facilitate a synchronized reporting of deficiencies from GMP audits. They were oriented on the principles of GMP components, including categorizing deficiencies based on the Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance on GMP deficiency classification, and discussed the best audit practices following the WHO Technical Report Series. WHO will continue to support the DDA in strengthening regulatory inspection capacity to meet international best practices and standards.
Training workshop on deficiency categorization of Good Manufacturing Practice (GMP) inspection and audit held
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