Yemen's pharmaceutical distribution sector faces critical challenges: weak regulatory oversight (with the National Regulatory Authority below WHO maturity level 3) and a prevalent non-compliance among local distributors with global GSDP standards. These vulnerabilities don't just jeopardize product quality and patient safety; they carry significant economic and reputational consequences.
Local distributors often find themselves excluded from high-value, donor-funded tenders and exposed to the risk of losing crucial partnerships with international pharmaceutical companies. This can drastically reduce their import lists for vital medicines, even leading to a complete withdrawal from the Yemeni market.
Qual-Med Yemen offers a strategic and innovative solution to these pressing challenges. Our GSDP Qualification & Certification Readiness Program (GSDP-QCRP) is a specialized initiative meticulously designed to rapidly enhance your operational compliance and align your storage, transportation, and distribution practices with globally recognized WHO GSDP standards. This program transforms you into a GSDP-certified partner, unlocking access to donor-funded projects, fostering international collaborations, and building unshakable trust with regulators, NGOs, and multinational pharma companies.
How Our Program Works: A 7-Phase Journey to GSDP Certification
Phase 1: Initiation & Planning
Establishing the foundation—kick-off, contractual alignment, documentation setup, and governance structures to ensure commitment and clarity.
Phase 2: Gap Assessment
Comprehensive audits to identify compliance gaps using WHO-aligned checklists. Risks are prioritized, and a tailored remediation plan is developed.
Phase 3: Quality System Design & Documentation
Development of a robust Quality Management System, including SOPs, a Quality Manual, and document/change control systems aligned with WHO GSDP.
Phase 4: Training & Competency Building
Delivery of expert-led training across nine GSDP modules, complemented by hands-on workshops and competency evaluations for operational teams.
Phase 5: Facility & Equipment Qualification
Execution of IQ/OQ/PQ protocols, temperature mapping, and equipment calibration to validate infrastructure readiness.
Phase 6: Mock Audit & CAPA Closure
A full-scope internal audit to simulate certification inspections, finalize CAPA actions, and confirm GSDP compliance readiness.
Phase 7: Certification Support & Handover
Prepare the complete certification package, liaise with external auditors, and issue your official “Certification Readiness” certificate.
