FDA 483 batch record issues – 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...

How to Handle Missing Batch Records During a GMP Audit

digi — Wed, 10 Sep 2025 08:43:22 +0000

How to Handle Missing Batch Records During a GMP Audit Managing Missing Batch Records During GMP Audits Introduction: Why This Topic Matters for GMP Compliance Batch records are one of the most critical documents in pharmaceutical manufacturing. They serve as the evidence that every step in the production, packaging, and testing process was executed according...