Aimed at empowering the central and state drug regulators with the similar regulatory knowledge as offered to their global counterparts, the Central Drugs Standard Control Organisation (CDSCO) is planning to equip its drug inspectors on relevant areas of good manufacturing practices (GMP), data integrity and audit readiness through specialised workshops to be held in November this year at Bengaluru and Ahmedabad respectively.
The workshops which will be on similar lines as was conducted jointly by the US FDA and CDSCO last year will update CDSCO and state drug inspectors on GMP practiced globally. The workshops earlier held in Hyderabad, Goa, Chandigarh and Ahmedabad in May, 2014 were aimed at addressing the regulatory needs of the industry and covered topics like process validation, enforcements and computer system validation based on out of specific information.
"A total of 100 drug inspectors with equal representation from CDSCO and state drug regulatory bodies from across the country will participate in each of the workshops to be held in Bengaluru and Ahmedabad between November 16 and November 19, 2015. The workshops will focus on GMP and data integrity," informed a senior CDSCO official.
The workshops held earlier for the pharma industry last year were oriented towards actionable steps that need to be taken, audit readiness and basics of inspections through a thematically, strategically and ethically aligned focus with US FDA and MHRA recommendations. They were meant to enable Indian pharma companies on compliances related to consent decree, Form 483, data integrity and quality management systems
Considering the fact that certain Indian companies have got critical global attention in the past couple of years due to certain violations and avoidances during US FDA inspections, these workshops, according to an official, will help the regulators get knowledge about GMP and quality management systems. Additionally, this would also provide knowledge nuggets and best practices on maintenance of electronic records for inspection-readiness.
Dr Margaret Hamburg, former commissioner US FDA, had also made a commitment in her visit to India in February last year to launch a set of workshops to bring the knowledge of global GMP standards to the Indian pharma.