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GVP intro

1. GVP Module V: Risk Management Systems Dr. Syed, Mankind Pharma

2. Purpose: Ensure proactive risk identification & minimization Mandatory for new and marketed products Based on ICH GVP Module V

3. Structured document describing product risksCovers : safety specification, PV plan, risk minimization planLiving document, updated throughout lifecycle

4. At time of marketing authorization application Post-approval: when new safety concerns emerge Periodic review (linked to PSUR/PBRER cycles)