pharmaceutical compliance audits – Pharma GMP

Harmonized GMP Audit Reports: Format, Content, and Cross-Agency Acceptance

digi — Thu, 22 May 2025 09:20:25 +0000

Harmonized GMP Audit Reports: Format, Content, and Cross-Agency Acceptance Harmonized GMP Audit Reports: Global Templates, Core Elements, and Regulatory Acceptance Good Manufacturing Practice (GMP) audit reports are essential records of regulatory inspections that document compliance status, identify deficiencies, and guide post-inspection actions. As pharmaceutical oversight becomes increasingly globalized, the push for harmonized GMP audit reports...

Common Elements Across Global GMP Inspection Systems

digi — Tue, 20 May 2025 11:16:07 +0000

Common Elements Across Global GMP Inspection Systems Exploring the Shared Frameworks in Global GMP Inspection Systems Despite the diversity of global pharmaceutical regulations, GMP inspection systems share numerous foundational elements. These commonalities enable regulatory collaboration, mutual recognition, and greater predictability for manufacturers operating across jurisdictions. This article explores the core elements universally observed in GMP...