In order to equip pharma manufacturing units for GMP compliance, Maharashtra Food and Drug Administration (FDA) is in the process of drafting a proforma to help 1703 existing manufacturers do self auditing of their units in accordance to global standards. The proforma will help generate a self inspection report of the unit for further review and recommendation from the state FDA for effective global compliance.
The proforma likely to be available soon to the manufacturers is the outcome of the fact that Indian pharma companies are of late being targeted in many importing countries and regulated markets. Regulatory regimes in the respective countries are being tightened by raising barriers to protect the domestic industry.
Says Maharashtra FDA Commissioner Mahesh Zagade, “With complaints received from countries like Vietnam very recently regarding supply of not of standard quality drugs, it becomes the responsibility of the Indian regulatory authorities to ensure that position of Indian pharma industry is not compromised in the international market. The objective is to account for what goes out of India.”
An FDA official further explains that generic drugs produced in the country have made inroads in both developing and developed markets of the world. Doing inspection through a set of procedures, therefore, is the need of the hour.
Audit readiness of pharma manufacturing units has also become a focus area following the US FDA’s workshops on GMP and CGMP compliance for the first time in four cities of India in partnership with Central Drugs Standard Control Organisation (CDSCO) last month. The US FDA –CDSCO workshops conducted recently covered relevant topics for Indian regulatory requirements like process validation, enforcements and computer system validation based on out of specific information. The workshops were held in Hyderabad, Goa, Chandigarh and Ahmedabad.
US-based online compliance and regulatory learning solutions company Underwriters Laboratories (UL) Eduneering, which trains drug regulators to ensure safety of FDA related pharma products is also planning to equip leading Indian pharma companies on maximizing compliances related to consent decree, Form 483, data integrity and quality management systems. This would entail maintenance of electronic records for inspection readiness of Indian companies.