Advanced in-country workshop on Good Manufacturing Practices for regulatory inspections using Quality Risk Management approach

As a part of the continued commitment for strengthening the National Regulatory Authority (NRA) in India, WHO conducted a five-day advanced workshop on Good Manufacturing Practices (GMP), for regulatory inspections by new drugs inspectors using the Quality Risk Management Approach.

The workshop was held at Pune from 14-18 November 2016.

The workshop enabled the regulatory inspectors supervising the vaccine manufacturers to improve their skills in conducting GMP inspections and acquire an in-depth knowledge about GMP requirements.

During the workshop, important topics such as ensuring vaccine quality and WHO policy; risk-based approach for facility design inspection; GMP inspection at bulk vaccine manufacturers (for bacterial, viral and recombinant vaccines); GMP requirements for aseptic processing; inspection of aseptic processing using risk management approach; writing effective inspection reports; and mock audit planning were discussed in detail.

Drug inspectors from Central Drugs Standard Control Organisation (CDSCO) headquarters, state drugs control departments, and Central Drug Laboratory, Kasauli were trained by an international team of experts from WHO.