The Maharashtra FDA will soon start risk based  inspections to check the compliance levels for good manufacturing practices (GMPs) following responses of self-audit from around 800 manufacturers in the state.

The state drug regulator had directed Schedule M units in the state to do self-auditing of the manufacturing sites before the inspection. Having scrutinized the self-audit checklist from respective manufacturers, the exercise will start shortly.

The inspections will check compliance on sanitation and hygiene, self-inspection, quality audits, prevention of cross-contamination and bacterial contamination during production, training employees among others.

Based on the current GMP and Good Laboratory Practices (GLP) under the Drugs & Cosmetics, Rules, 1945, the World Health Organisation (WHO),  GMPs and requirements in terms of Pharmaceutical Inspection Cooperation Scheme (PICS), the Central Drugs Standard Control Organisation (CDSCO)  developed a comprehensive checklist for Risk Based Inspection of  pharmaceutical manufacturing units in the country in 2016.

Further, on the basis of a careful analysis of the risks involved, the CDSCO identified a number of companies manufacturing drugs in the country for being inspected in terms of the aforesaid criteria.  

“Now since we have the self-audit reports of manufacturers, we will be able to identify the non-compliant units and carry risk based inspections accordingly towards effective GMP compliance and hence drug quality,” says a senior FDA official.

The responses on the check list for self audit by the concerned manufacturers is meant to assess adherence to the licensing conditions as envisaged in the Drugs and Cosmetics Act.  

To maintain quality standards in manufacturing facilities, the Central Drugs Standard Control Organisation (CDSCO) last year concluded 185 risk based inspections in 8 phases as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945.

These risk based inspections are based on a checklist issued for the state drug regulators to ensure that there is uniformity of inspections across all the Schedule M units in the country. CDSCO checklist and evaluation is also aimed at streamlining uniform inspection procedures across the country related to GMP.

The inspections are planned and carried out jointly by the CDSCO officials and drug inspectors of the States concerned. The checklist and tool is meant to also help CDSCO and state drug regulators to understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant.