Maha FDA, CDSCO Start Risk-Based Inspections Of Sch M Units For Compliance To Norms

Mumbai, 17 Aug 2018: Following responses of self-audit from around 800 manufacturers in the state, the Maharashtra Food and Drug Administration (FDA) has started risk-based inspections for an effective oversight on the drug manufacturers in the state for compliance to good manufacturing practices (GMPs).

There is a growing receptiveness towards US FDA investigations today with a risk-based approach to address quality issues of a pharmaceutical product and API facility. There is also an urgent need to address the increasing number of US FDA inspections and to be equipped to avoid last minute rush, according to regulatory experts. 

“The risk-based inspections which are jointly conducted by the state FDA and Central Drugs Standard Control Organisation (CDSCO) will check manufacturer's compliance on sanitation, hygiene, self-inspection, quality audits, prevention of cross-contamination and bacterial contamination during production among other critical areas,” informed a senior FDA official.

“Risk based inspections has become a top priority for the state drug controller as self-audit reports of drug manufacturers have been reviewed,” the FDA official added.

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.

Other state drug controllers have also started equipping themselves to deal with data integrity issues and address FDA expectations through a robust quality control (QC) system.

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 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.

To maintain quality standards in manufacturing facilities, the 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. 

The checklist and tool is meant to also help CDSCO and state drug regulators to understand and collaborate which pharmaceutical and API manufacturing sites have been inspected and are found to be compliant. Pharmabiz