13 October 2025 – Aiding the Lebanese National Regulatory Agency in developing a national plan to improve Good Manufacturing Practices (GMP) standards among local pharmaceutical manufacturers, a project launched by WHO Lebanon and supported by the European Union, will advance the regional flagship initiative on expanding equitable access to medical products.
The high-level GMP mission scheduled for October 2025 includes comprehensive training for over 25 pharmacy inspectors, an assessment of GMP compliance among local pharmaceutical manufacturers and the formulation of a national development plan to enhance GMP standards.
The mission commenced with targeted training sessions for Ministry of Public Health (MoPH) pharmacist inspectors on GMP principles. The training has been designed to strengthen Lebanon’s pharmaceutical regulatory framework and drive progress towards membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Day 1 – Orientation and introduction to international GMP standards
The opening day focused on acquainting inspectors with WHO GMP guidelines, the PIC/S framework and the strategic objectives of the GMP strengthening initiative. Opening remarks from WHO and MoPH leadership underscored Lebanon’s dedication to ensuring the quality, safety and efficacy of locally manufactured medicines and aligning with international regulatory standards.
Participants attended presentations on the structure, principles and scope of GMP, including responsibilities related to quality assurance, documentation control and validation. Special attention was given to the evolution of GMP standards globally and their critical role in enhancing market access, export potential and patient safety.
Interactive discussions reviewed Lebanon’s current GMP landscape, identifying key challenges such as fragmented regulatory oversight, the absence of accredited laboratories and lack of local bioequivalence centres.
The day concluded with an overview of the PIC/S accession process, highlighting the benefits – enhanced credibility, mutual recognition of inspections, improved capacity for risk-based inspections in line with international best practices – of membership.
Day 2 – Inspection methodology and practical applications
The second day concentrated on equipping inspectors with the practical skills needed for GMP inspection planning and execution. A WHO expert introduced a standardized inspection checklist aligned with WHO and PIC/S guidelines and verification documentation to ensure consistency and transparency.
Training covered all inspection phases, including pre-inspection preparation, on-site verification and post-inspection reporting, emphasizing observation classification and the formulation of corrective and preventive action (CAPA) plans. Simulated inspection scenarios within local manufacturing facilities enabled participants to apply theoretical knowledge in practical contexts.
Sessions emphasized normative consistency, confidentiality and the responsibilities of inspectors as protectors of public health. The training also promoted a shift from punitive inspection approaches towards a mentorship model that supports continuous quality improvement within Lebanon’s pharmaceutical sector.
The initial 2 days of training established the foundation for a unified national inspection framework aligned with WHO and PIC/S standards. This capacity-building effort is critical to strengthening Lebanon’s National Regulatory Authority, enhancing confidence in domestically produced medicines and advancing Lebanon’s pursuit of PIC/S membership, a milestone that will elevate international recognition of its regulatory system and improve access to quality-assured medicines.
Following the training phase, extensive on-site mentoring and inspections will be conducted by GMP consultants across Lebanon’s 12 active pharmaceutical manufacturing sites, consolidating the skills and standards developed during the mission.
