GMP harmonization challenges – Pharma GMP

Inspection Variability in Latin American Regulatory Systems

digi — Wed, 25 Jun 2025 01:45:33 +0000

Inspection Variability in Latin American Regulatory Systems Managing Inspection Variability in Latin American Regulatory Systems The pharmaceutical industry in Latin America is governed by diverse regulatory frameworks that impact the frequency, scope, and structure of Good Manufacturing Practice (GMP) inspections. While efforts at regional harmonization exist, significant differences remain across national agencies like ANVISA (Brazil),...

How to Navigate Cross-Country GMP Inspection Variability

digi — Sun, 22 Jun 2025 03:49:39 +0000

How to Navigate Cross-Country GMP Inspection Variability Effective Strategies to Navigate Variability in Cross-Country GMP Inspections As pharmaceutical supply chains stretch across continents, manufacturers face the challenge of meeting Good Manufacturing Practice (GMP) expectations from a diverse set of regulatory authorities. While global harmonization is underway, there remains considerable variability in cross-country GMP inspections. This...