WHO Prequalification and Inspection Systems

WHO Inspector Training and Qualification Process

May 28, 2025 digi

WHO Inspector Training and Qualification Process Inside the WHO Inspector Training and Qualification Process The World Health Organization (WHO) plays a pivotal role in assuring the global supply of safe, effective, and high-quality medicines through its Prequalification Programme (PQP). Central to this effort is the deployment of highly trained GMP inspectors. The WHO inspector training…

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

Role of WHO Collaborative Registration Procedure (CRP) in GMP Compliance and Market Access

May 28, 2025 digi

Role of WHO Collaborative Registration Procedure (CRP) in GMP Compliance and Market Access Leveraging WHO’s Collaborative Registration Procedure (CRP) for GMP Compliance and Global Market Access For pharmaceutical manufacturers aiming to expand access to essential medicines, navigating diverse national registration systems can be challenging. The WHO Collaborative Registration Procedure (CRP) offers a powerful mechanism to…

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

Country Participation in WHO Joint Inspections

May 28, 2025 digi

Country Participation in WHO Joint Inspections Country Participation in WHO Joint Inspections: Strengthening GMP Oversight through Collaboration As pharmaceutical manufacturing grows increasingly globalized, collaboration between international and national regulators has become essential. One of the most impactful strategies in this regard is country participation in WHO joint inspections. These inspections, conducted under the World Health…

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

How WHO Prequalification Enhances Market Access

May 29, 2025 digi

How WHO Prequalification Enhances Market Access How WHO Prequalification Enhances Market Access for Pharmaceutical Manufacturers Global market access for essential medicines requires more than quality products—it demands recognition of regulatory compliance and supply chain trust. The WHO Prequalification Programme (PQP) serves as a powerful enabler of such access. Through a rigorous system of dossier evaluation…

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

WHO Inspection Follow-Up: CAPA and Compliance Monitoring

May 29, 2025 digi

WHO Inspection Follow-Up: CAPA and Compliance Monitoring WHO Inspection Follow-Up: Managing CAPA and Ensuring GMP Compliance The conclusion of a WHO GMP inspection does not mark the end of the evaluation process—it signals the beginning of a critical compliance phase. Pharmaceutical manufacturers must respond to observations through structured Corrective and Preventive Action (CAPA) plans and…

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

GMP Requirements for WHO PQP Requalification

May 29, 2025 digi

GMP Requirements for WHO PQP Requalification Understanding GMP Requirements for WHO PQP Requalification Maintaining WHO Prequalification status is as critical as obtaining it. For pharmaceutical manufacturers, requalification under the WHO Prequalification Programme (PQP) is a mandatory process to ensure continued compliance with international GMP standards. WHO’s GMP requalification process involves reassessment of manufacturing sites, documentation,…

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

Documentation Standards for WHO GMP Compliance

May 29, 2025 digi

Documentation Standards for WHO GMP Compliance Mastering Documentation Standards for WHO GMP Compliance Documentation is the cornerstone of Good Manufacturing Practices (GMP), providing verifiable evidence of quality, consistency, and compliance. In the context of the WHO Prequalification Programme (PQP), manufacturers must meet rigorous documentation standards to obtain and maintain compliance. This article explores the critical…

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

WHO PQP Public Assessment Reports: Structure and Utility

May 30, 2025 digi

WHO PQP Public Assessment Reports: Structure and Utility WHO PQP Public Assessment Reports: Format, Purpose, and Strategic Use One of the hallmarks of the WHO Prequalification Programme (PQP) is transparency. This is exemplified through the publication of Public Assessment Reports (PARs), which summarize the outcome of the WHO PQ evaluation of pharmaceutical products. These documents…

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

Cross-Agency Coordination in WHO Inspections

May 30, 2025 digi

Cross-Agency Coordination in WHO Inspections Cross-Agency Coordination in WHO Inspections: Strengthening Global GMP Synergy In today’s interconnected pharmaceutical landscape, effective oversight demands coordination beyond individual agencies. The World Health Organization (WHO), through its Prequalification Programme (PQP), spearheads cross-agency coordination in GMP inspections to harmonize standards, reduce redundancies, and strengthen compliance mechanisms globally. This article explores…

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

How to Maintain WHO PQP Status Over Time

May 30, 2025 digi

How to Maintain WHO PQP Status Over Time How to Sustain WHO Prequalification Status Through Ongoing GMP Compliance Achieving WHO Prequalification (PQP) is a significant milestone for pharmaceutical manufacturers—but sustaining it is an ongoing regulatory commitment. The WHO requires manufacturers to demonstrate continuous compliance with GMP, quality systems, and dossier maintenance throughout the product lifecycle….

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