The CDSCO, in collaboration with WHO, organised a five-day workshop to impart training to the Drugs Inspectors on Basic GMP using Quality Risk Management Approach in Hyderabad from 3-7 November 2014.
The main objective of the workshop was to impart training to the Drugs Inspectors (DIs) of CDSCO for inspection of the vaccine units as per Basic GMP norms so as to enable them to maintain the safety, efficacy and standards of vaccines in the country. The DIs recruited in the recent past at CDSCO Zonal, Sub- Zonal Offices and at CDSCO (HQ), are often deputed to participate in the joint inspection with DIs from state drug control departments and experts from CDL Kasauli to various vaccine manufacturing facilities located under the jurisdiction of CDSCO Zonal Offices.
Other objectives of the workshop are to ensure that the regulatory inspection functions of the NRA in the India will be performed against the WHO recommended standards; update the NRA IDP in order to ensure proper enforcement of GMP in all Indian vaccine manufacturers; all regulatory inspectors supervising vaccine manufacturing firms will improve their skills in conducting competent and efficient GMP inspections using risk management approach; all regulatory inspectors supervising vaccine manufacturers will improve and update their knowledge on GMP requirements; and newly recruited DIs can grasp the basics of vaccine manufacturing, risk-based approach of inspection and fulfilling the gaps in existing Schedule M and the WHO GMP.
As a part of NRA strengthening activities and capacity building, CDSCO had recruited 90 DIs in the year 2013. The Institutional Development plan which was made with WHO for the year 2012-2015 included GMP Regulatory Inspection (Basic and advanced).The Dis have duties and responsibilities to discharge the functions under D&C Act and Rules and other job responsibilities such as inspections for certification of pharmaceutical products as per WHO norms etc. The workshop of this nature helps in focussing on various aspects of the job description of DIs by way of interaction with experts from pharmaceutical industry, & vaccine industry by way of audio visual presentation and hands on experience practically by field visits.