GMP documentation errors – Pharma GMP

Common GMP Issues in Tablet Manufacturing

digi — Thu, 04 Sep 2025 12:50:38 +0000

Common GMP Issues in Tablet Manufacturing Frequent GMP Challenges in Tablet Manufacturing and How to Address Them Introduction: Why This Topic Matters for GMP Compliance Tablet manufacturing, as a major component of oral solid dosage (OSD) production, is subject to strict regulatory oversight. Global agencies such as the FDA, EMA, and WHO closely examine GMP...

GMP Inspection Trends Observed in Recent FDA Reports

digi — Fri, 06 Jun 2025 21:00:53 +0000

GMP Inspection Trends Observed in Recent FDA Reports Recent Trends in FDA GMP Inspections: Key Observations and Compliance Focus Each year, the US Food and Drug Administration (FDA) releases a wealth of data on GMP inspection findings, including Form 483 observations, enforcement actions, and emerging areas of regulatory concern. These insights help pharmaceutical manufacturers proactively...

Common GMP Violations Noted in FDA 483s

digi — Mon, 02 Jun 2025 22:41:56 +0000

Common GMP Violations Noted in FDA 483s Common GMP Violations Identified in FDA Form 483 Observations Every US FDA inspection culminates in a detailed evaluation of GMP compliance, and when deficiencies are observed, they are formally documented on Form 483. These observations offer critical insights into systemic and operational gaps that may compromise product quality...