Tag: global GMP compliance

GMP Surveillance Audits: Global Best Practices

May 22, 2025 digi

GMP Surveillance Audits: Global Best Practices Mastering GMP Surveillance Audits: Global Best Practices for Compliance Surveillance audits are critical tools used by regulatory agencies to ensure ongoing compliance with Good Manufacturing Practices (GMP). These audits provide periodic, independent assessments of a pharmaceutical facility’s adherence to quality systems, documentation, and regulatory expectations. While surveillance inspections may…

Global GMP Inspection Frameworks, International GMP Inspection Standards and Harmonization

Impact of Harmonization on International Pharmaceutical Trade and Compliance

May 21, 2025 digi

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…

Global GMP Inspection Frameworks, International GMP Inspection Standards and Harmonization

GMP Inspection Classifications: Routine, For-Cause, and Special Inspections

May 20, 2025 digi

GMP Inspection Classifications: Routine, For-Cause, and Special Inspections Decoding GMP Inspection Types: Routine, For-Cause, and Special Audits Good Manufacturing Practice (GMP) inspections are a cornerstone of pharmaceutical regulatory oversight. However, not all inspections are alike. Regulatory authorities around the world categorize inspections based on their purpose, risk level, and triggers. For Pharma Professionals aiming to…

Global GMP Inspection Frameworks, International GMP Inspection Standards and Harmonization