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Based on the responses of self-audit from around 800 manufacturers in the state, the Maharashtra Food and Drug Administration (FDA) will start surprise inspections to check the compliance levels for adherence to good manufacturing practices.
The exercise will start shortly as respective compliance reports of self assessment from manufacturers have been submitted to the state regulator and scrutinized based on the checklist shared. The state drug regulator had directed Schedule M units in the state to do self-auditing of the manufacturing sites before the inspection.
The responses on the check list 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.
To maintain quality standards in manufacturing facilities, the Central Drugs Standard Control Organisation (CDSCO) has also started another phase of risk based inspections across the country to verify good manufacturing practices (GMP) compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945. CDSCO 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 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 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.
GMPs is based on a criteria involving factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personnel. Global GMP violations have hurt India’s image as an inexpensive and reliable supplier of generics in international markets.
CDSCO also plans to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP standards.
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