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Maha FDA examines check-list of self audits from drug manufacturers to verify GMP compliance

Shardul Nautiyal, Mumbai
Thursday, February 8, 2018, 08:00 Hrs  [IST]

The Maharashtra Food and Drug Administration (FDA) is currently examining check-list of self audits from around 800 manufacturers across the state to verify compliance to good manufacturing practices (GMP). A panel of seven joint commissioners has been formed to review the check-list and take subsequent action based on the same.

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.

“This is primarily done to maintain compliance levels achieved so far over the past several years for the very reason that Maharashtra has been amongst the most regulated states. Central Drugs Standard Control Organisation (CDSCO) has appreciated our efforts towards conducting similar kind of exercise with 70,000 drug retailers in the state,” informed Maharashtra FDA Commissioner Pallavi Darade.

Joint inspections will follow post the verification exercise, she added.

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.

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 concluded 185 risk based inspections in 8 phases last year.

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.


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vijay naik Feb 8, 2018 11:21 AM
a very good step for pharma and bulk drug company.
suggesting for national level it is to be made.

this will help Indian company to clear national and international level of FDA inspection.

congratulation to government authorities for this initiative.
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