EMA Annex 11 documentation – Pharma GMP

How to Format Your SOP for Logbook Corrections

digi — Sat, 13 Sep 2025 00:26:52 +0000

How to Format Your SOP for Logbook Corrections Formatting a GMP-Compliant SOP for Logbook Corrections Introduction: Why This Topic Matters for GMP Compliance Logbooks are critical GMP records that provide evidence of equipment use, cleaning, calibration, and monitoring activities. Mistakes in logbook entries are inevitable, but how those errors are corrected determines whether the records...

How to Set Up a True Contemporaneous Recording System

digi — Fri, 12 Sep 2025 04:12:10 +0000

How to Set Up a True Contemporaneous Recording System Building a True Contemporaneous Recording System for GMP Compliance Introduction: Why This Topic Matters for GMP Compliance In Good Manufacturing Practice (GMP), documentation is not just a formality—it is evidence that processes were executed as required to ensure product quality and patient safety. A cornerstone of...