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CDSCO,, Maharashtra FDA To Conduct Joint Inspections Of Schedule M Units Across State To Verify GMP Compliance

CDSCO,, Maharashtra FDA To Conduct Joint Inspections Of Schedule M Units Across State To Verify GMP Compliance


Mumbai, 18 Dec 2017: The Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra Food and Drug Administration (FDA) will soon conduct joint inspections of Schedule M units across the state to verify the compliance to good manufacturing practices (GMP).

 

Meanwhile, Maharashtra FDA is in the process of verifying compliance reports of self -audits done by around 800 manufacturers in the state. Schedule M units in the state were earlier directed to do self-auditing of the manufacturing sites based on issuance of check list by the state regulator before an inspection.

 

“We are currently verifying the adherence to the compliance by the schedule M units based on the responses received and joint inspections will soon follow post the verification exercise,” informed Maharashtra FDA Commissioner Pallavi Darade.

 

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

 

The CDSCO has also been conducting risk based inspections across the country to verify GMP compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945. It recently concluded 185 risk based inspections in 8 phases.

 

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 checklist and tool is meant to 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.