Tag: risk-based GMP audits

CDSCO Audit Frequency and Risk Profiling Criteria

June 22, 2025November 14, 2025 digi

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…

Country-Specific Inspection Standards (e.g., UK MHRA, US FDA, TGA), International GMP Inspection Standards and Harmonization

EMA’s Risk-Based GMP Inspection Planning

June 7, 2025 digi

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…

EMA and EU GMP Inspection Practices, International GMP Inspection Standards and Harmonization

Understanding WHO’s Risk-Based Inspection Model

May 28, 2025 digi

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…

International GMP Inspection Standards and Harmonization, WHO Prequalification and Inspection Systems