At a glance
The CHMP supports the National Agency for Medicines and Medical Evacuations (ANAMEV) in preparing its national medicines quality control laboratory (LNCQ). The technical assistance combines infrastructure assessment, laboratory organisation, staff training and the development of a sustainable operating model.
The assignment is part of the COVID-19 vaccine acquisition and health system strengthening project. GIMOPHARM contributes practical laboratory training in France.
Context
The Union of the Comoros relies on imported medicines. Building national quality control capacity will support the monitoring of products on the market and help address substandard and falsified medicines.
Preparing the laboratory requires coordination between premises, equipment selection, staff skills and working procedures. The project takes a phased approach suited to national needs and available resources.
Objectives
- Prepare the technical and organisational conditions for laboratory start-up.
- Match equipment and consumables to planned analytical activities and available space.
- Train the team in good practices, working methods and the use of essential equipment.
- Establish a quality system and document management arrangements.
- Define staffing needs and a sustainable economic model.
Areas of support
Infrastructure and equipment. The CHMP assessed the plans and premises, reviewed equipment lists and made recommendations on equipment layout, workflows, electrical supply and IT requirements. Support also covers procurement specifications and continuity of analytical operations.
Training and skills transfer. Remote sessions covered good laboratory, manufacturing, distribution and documentation practices, along with the operating principles of analytical equipment. These were complemented by procedure-writing workshops and practical immersion at GIMOPHARM under real laboratory conditions.
Quality system. Support includes procedures tailored to ANAMEV, training records and the preparation of document management arrangements. The aim is to establish shared working methods from start-up and embed them in daily operations.
Organisation and sustainability. A human resources plan and business plan set out the required roles, skills development needs, priority analytical activities and conditions for phased development. The projections support decisions on the laboratory’s long-term operation.
Documented progress
- August 2025: assignment inception, initial infrastructure assessment and review of equipment needs.
- September to November 2025: remote training and support for drafting quality system procedures.
- November 2025: practical immersion for three team members at GIMOPHARM, in two groups.
- December 2025: technical review, equipment and premises recommendations, human resources plan and preparation of the business plan.
- April 2026: final version of the laboratory business plan.
The next steps concern operational readiness: completing the premises, installing equipment, supporting commissioning and consolidating the quality system. Additional support for IT infrastructure is also being explored.
Partners and delivery context
- ANAMEV: beneficiary institution and team of the future national quality control laboratory.
- CHMP: technical assistance, coordination, training and organisational support.
- GIMOPHARM: host for practical laboratory training in France.
- COVID-19 vaccine acquisition and health system strengthening project: framework for the assignment.