The WHO Country Office for India in collaboration with the Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce and Industry (FICCI) recently organized the ‘Regional Good Manufacturing Practices Strengthening Workshop’, for Indian pharmaceutical manufacturers and state regulators. Workshops were conducted in Ahmedabad, Bangalore and Goa. The workshops focused on Good Manufacturing Practices (GMP) in production of Active Pharmaceutical Ingredients and Oral Solid Dosage Forms.
The workshops were aimed at building the capacities of small and medium enterprises (SMEs) in strengthening Quality Management Systems and disseminate best practices for the process improvements, global regulatory requirements and compliance, including WHO Good Manufacturing Practices (GMP) requirements.
These workshops presented an opportunity to discuss the following critical topics: position of Indian manufacturers in global supply of essential medicines and in WHO Prequalification of Medicines scheme; recent Good Manufacturing Practices (GMP) developments and trends, including guidelines from Pharmaceutical Inspection Cooperation Scheme (PIC/S), WHO; EU Commission and Scheme M; most common observations, experiences, conclusions and remedial actions from PIC/S and DCGI inspections in India; good documentation practice; data integrity and verification, including hands-on exercise and assessment; and management of cross-contamination risk.
Several national and international experts of repute, including faculty from WHO Prequalification team, Department of Essential Medicines and Health Products and Medicines and Healthcare Products Regulatory Agency (MHRA) participated and shared best practices, experiences and perspectives from across the globe.