Definition

Inspection of pharmacovigilance systems by CDSCO or state authorities in India; may cover QPPV, case processing, reporting to PvPI, and documentation.

Example

Preparation of PV SOPs, training records, and case files for CDSCO inspection.

Regulatory source

CDSCO inspection guidelines, Drugs and Cosmetics Rules

Common mistakes

Lack of India-specific SOPs or QPPV contact for India.

Inspector question

How do you prepare for a CDSCO PV inspection?

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