pharma documentation culture – Pharma GMP

Electronic Batch Records (EBR) vs Manual: GMP Pros and Cons

digi — Fri, 12 Sep 2025 18:15:03 +0000

Electronic Batch Records (EBR) vs Manual: GMP Pros and Cons Electronic Batch Records vs Manual Systems: Pros and Cons for GMP Compliance Introduction: Why This Topic Matters for GMP Compliance Batch records are central to demonstrating Good Manufacturing Practice (GMP) compliance. They document every stage of drug production, packaging, and quality control, serving as proof...

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,...

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...