CDSCO mandates submission of report on compliance with Good Manufacturing Practices / Good Laboratory Practices by 30th August, 2017

CDSCO mandates submission of report on compliance with Good Manufacturing Practices / Good Laboratory Practices by 30th August, 2017

September 12, 2017 Industry Specific 0

In a recent notice dated 9th August, 2017, the Central Drugs Standard Control Organization (“CDSCO”) has mandated all drug manufacturers and pharmaceutical associations to submit self-assessment and self-audit reports of their units. These reports must state compliance with Good Manufacturing Practices (“GMP”) (Schedule M) / Good Laboratory Practices (“GLP”) (Schedule L-1) as required under the Drugs and Cosmetics Rules, to the State Licensing authorities and CDSCO by 30th August, 2017.

Towards implementation in this regard, the CDSCO had prepared a detailed checklist for manufacturing units to comply with such requirements, with a view to ensure that each manufacturing unit carries out self-assessment of GMP / GLP compliance by assigning quality rating based on benchmarks provided by CDSCO. 

Source: Central Drugs Standard Control Organization

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