risk-based GMP audits – Pharma GMP

CDSCO Audit Frequency and Risk Profiling Criteria

digi — Sun, 22 Jun 2025 20:33:30 +0000

CDSCO Audit Frequency and Risk Profiling Criteria Decoding CDSCO’s Audit Frequency and Risk Profiling Criteria for GMP Inspections India’s Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in regulating pharmaceutical manufacturing under the Drugs and Cosmetics Act. One of the most significant advancements in its regulatory approach is the implementation of a risk-based...

EMA’s Risk-Based GMP Inspection Planning

digi — Sat, 07 Jun 2025 20:38:53 +0000

EMA’s Risk-Based GMP Inspection Planning How EMA Applies Risk-Based Planning for GMP Inspections in the EU The European Medicines Agency (EMA), together with the national competent authorities (NCAs) of EU Member States, uses a sophisticated risk-based approach to plan and conduct GMP inspections. This strategy ensures efficient allocation of resources while maintaining robust oversight of...

Understanding WHO’s Risk-Based Inspection Model

digi — Wed, 28 May 2025 06:16:05 +0000

Understanding WHO’s Risk-Based Inspection Model Decoding WHO’s Risk-Based Inspection Model for GMP Oversight In the evolving landscape of pharmaceutical regulation, resource-efficient oversight is critical. The World Health Organization (WHO) has adopted a risk-based inspection model under its Prequalification Programme (PQP) to prioritize GMP inspections for pharmaceutical manufacturers. This model helps determine inspection frequency, scope, and...