regulatory harmonization challenges – Pharma GMP

Challenges in Aligning National Regulations with Global GMP Inspection Practices

digi — Sun, 25 May 2025 10:31:41 +0000

Challenges in Aligning National Regulations with Global GMP Inspection Practices Barriers to Aligning National Regulations with Global GMP Inspection Practices In an increasingly interconnected pharmaceutical industry, the goal of harmonized Good Manufacturing Practice (GMP) inspection standards remains a high priority. However, numerous challenges in aligning national regulations with global GMP practices persist. Differences in interpretation,...

Impact of Harmonization on International Pharmaceutical Trade and Compliance

digi — Wed, 21 May 2025 03:40:28 +0000

Impact of Harmonization on International Pharmaceutical Trade and Compliance How Harmonized GMP Inspections Strengthen Global Trade and Compliance Pharmaceutical manufacturers today operate in a globalized environment, supplying medicines across continents. Regulatory expectations, however, can vary widely—posing challenges for ensuring timely product approvals and consistent quality assurance. The harmonization of GMP inspection frameworks has emerged as...