regulatory inspection – Pharma GMP

Maintain Batch Records in Archival Systems for Regulatory Durations

digi — Sun, 17 Aug 2025 04:40:40 +0000

Maintain Batch Records in Archival Systems for Regulatory Durations Retain Batch Records in Controlled Archives for GMP Compliance Remember: Always retain batch records in secure archival systems for the duration mandated by GMP to ensure full traceability and regulatory readiness. Why This Matters in GMP Batch manufacturing records (BMRs) are core GMP documents that provide...

Never Skip Root Cause Analysis During GMP Deviation Investigations

digi — Tue, 27 May 2025 05:09:43 +0000

Never Skip Root Cause Analysis During GMP Deviation Investigations Root Cause Analysis Is Mandatory in All GMP Deviation Investigations Remember: Every deviation must undergo root cause analysis to implement meaningful corrective and preventive actions (CAPAs). Why This Matters in GMP When deviations occur, simply documenting them is not sufficient—underlying causes must be identified and addressed...