India’s CDSCO Issues Guidance on How to Conduct GMP Inspections

Posted 08 August 2014 By Louise Zornoza, RegLink News

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India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on 6 August 2014 to all local State Drugs Controllers setting forth uniform procedures on how to conduct good manufacturing practice (GMP) inspections of local pharmaceutical manufacturing facilities. 

Local inspectors are to focus on the GMP requirements for establishing shelf life, validation studies, and ensuring prompt recalls of non-compliant products when necessary. 

The inspection should last between two and five days (depending on the size and complexity of the manufacturing site) and regulatory action is to be undertaken immediately in those cases where inspection observations have uncovered conditions that could compromise drug quality, safety and efficacy.  CDSCO also states that the report of the inspection findings that prompted regulatory action should be finalized without delay at the end of the inspection.

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Categories: Biologics and biotechnology, Drugs, Compliance, Manufacturing, Quality, News, India, CDSCO

Tags: CGMP, GMP, Inspections

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