GMP record falsification – Pharma GMP

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,...

Why Backdated Entries Trigger Data Integrity Violations

digi — Wed, 10 Sep 2025 17:59:13 +0000

Why Backdated Entries Trigger Data Integrity Violations Backdated Entries and Their Impact on GMP Data Integrity Introduction: Why This Topic Matters for GMP Compliance In pharmaceutical manufacturing, accuracy and integrity of records are paramount. Every entry in a logbook, batch record, or laboratory notebook serves as proof that GMP processes were executed as required. Backdating...