pharma audit findings documentation – Pharma GMP

SOP Template: How to Handle Record Corrections Legally

digi — Fri, 14 Nov 2025 10:42:26 +0000

SOP Template: How to Handle Record Corrections Legally SOP Template for Handling GMP Record Corrections Legally Introduction: Why This Topic Matters for GMP Compliance Record corrections are a normal part of pharmaceutical documentation, but if not handled properly, they can raise concerns about data integrity and falsification. Regulators such as FDA, EMA, and WHO explicitly...

Root Cause Analysis of Repeated Documentation Deviations

digi — Sun, 14 Sep 2025 08:49:19 +0000

Root Cause Analysis of Repeated Documentation Deviations Root Cause Analysis for Repeated Documentation Deviations in GMP Introduction: Why This Topic Matters for GMP Compliance Documentation is the backbone of GMP compliance. It provides verifiable proof that manufacturing and testing processes were performed according to approved procedures. Yet, documentation deviations—errors, omissions, or failures to follow SOPs—remain...

GMP Rule: Why You Should Never Use Correction Fluid

digi — Fri, 12 Sep 2025 10:16:24 +0000

GMP Rule: Why You Should Never Use Correction Fluid Why Correction Fluid Is Strictly Prohibited in GMP Documentation Introduction: Why This Topic Matters for GMP Compliance In pharmaceutical manufacturing, documentation serves as the legal and scientific record of activities performed. Regulators such as the FDA, EMA, and WHO consistently emphasize that records must be complete,...