Terms of Reference for Consultancy for the Development and Operationalization of Standard Operating Procedures (Sops) for in-house Quality Control for Health Commodities in Rwanda

TERMS OF REFERENCE

Consultancy for the Development and Operationalization of Standard Operating Procedures (SOPs) for In-House Quality Control for Health Commodities in Rwanda

1. Background

NOURISH (Nurture the ecosystem, Optimise the market, Unlock financing, Reinforce ANC platforms, Integrate and Scale MMS and Calcium for Healthy Future) was launched in Rwanda in February 2026. The initiative aims to strengthen the antenatal care (ANC) system and scale access to multiple micronutrient supplementation (MMS) for pregnant women across the country. This supports the Government of Rwanda’s efforts to transition from iron and folic acid supplementation (IFAS) to MMS nationwide and reaffirms the collective commitment that MMS can be delivered at scale through Rwanda’s ANC platforms.

A critical enabler of the successful nationwide rollout of MMS is assurance of the quality and safety of the supplements provided to pregnant women. In Rwanda, the regulation and quality control of medicines and health commodities is led by the Rwanda Food and Drugs Authority (Rwanda FDA), the national regulatory authority mandated to protect public health through the registration, inspection, post-market surveillance, and laboratory testing of regulated products. In-house quality control of MMS, carried out through Rwanda FDA’s Quality Control Laboratory, is essential to building public trust and programme credibility.

Through NOURISH, Sight and Life aims to assist the Government of Rwanda to strengthen the in-house quality control of MMS and other health commodities by supporting the development or updating of the existing Standard Operating Procedures (SOPs) for quality control and laboratory testing. This includes equipping Rwanda FDA staff with clear, MMS programme-specific guidance and the capacity to execute it effectively — contributing to a more robust and credible quality assurance system for MMS and ensuring that every pregnant woman has consistent access to safe, high-quality supplementation.

2. Objectives

The overall aim of this assignment is to evaluate the existing SOPs for the quality control and laboratory testing of health commodities, and build the capacity of Rwanda FDA staff to execute these SOPs effectively for the in-house quality control. 

The specific objectives are:

• To perform a needs assessment of existing SOPs and guidelines relevant to in-house quality control and laboratory testing including MMS and detect gaps.
• To create new or update existing SOPs based on the findings of the needs assessment.
• To build the capacity of target staff through a refresher training programme based on the validated SOPs.
• To establish a monitoring framework to track SOP compliance and quality control performance.

3. Scope of Work

3.1 Key Tasks

The consultant will be tasked with the following:

1. evaluate existing national quality control SOPs, standard testing procedures (STPs), and guidelines, and detect gaps relevant to the MMS programme.
2. perform key informant interviews and consultations with stakeholders at the national level (Rwanda FDA, other relevant government institutions and partners).
3. Produce a Needs Assessment Report summarising findings, gaps, and prioritised recommendations for SOP development or revision.
4. create new or update existing SOPs covering sampling and sample reception, registration and verification of products, laboratory testing and analytical methods in-country testing protocols, benchmarking against international standards, results reporting and documentation, and quality management.
5. Facilitate stakeholder evaluate and a validation workshop to finalise SOPs.
6. create training materials, design and deliver a refresher training programme for Rwanda FDA staff , based on the validated SOPs.
7. Propose a monitoring and supervision framework to track SOP compliance and quality control performance indicators.

3.2 Methodology

The consultant will employ a mixed set of approaches appropriate to each stage of the assignment:

• Desk evaluate of existing SOPs, standard testing procedures, training materials, guidelines, and policy documents relevant to quality control and the MMS programme.
• Key informant interviews and consultations with stakeholders including MoH/RBC, Rwanda FDA and development partners to assess current practices and detect gaps.
• Facilitation of a stakeholder validation workshop to evaluate, refine, and formally endorse the proposed SOPs.
• Design and delivery of a refresher training programme, including development of training materials (facilitator guide, participant handbook, presentations, and exercises).
• Any additional activities identified as necessary in the course of the assignment to meet the stated objectives.

4. Deliverables and Expected Outputs

The consultant will be expected to produce the following outputs. All deliverables shall be submitted in English and approved by the Programme Manager before being considered final:

• Inception Report: Detailed work plan, methodology, and list of documents and stakeholders for the assignment, submitted within seven (7) days of contract signature.
• Needs Assessment Report: Comprehensive evaluate of existing SOPs and guidelines, gap analysis, and prioritised recommendations for SOP development or revision.
• Draft SOPs Package: Draft SOPs for all areas listed under Key Tasks, with accompanying job aids and quick reference tools for the quality control laboratory and testing functions.
• Stakeholder Engagement Record: Documented minutes, attendance lists, and summaries of all meetings, workshops, and consultations conducted during the assignment.
• Training Materials Package: Facilitator guide, participant handbook, presentations, and practical exercises for the quality control refresher training programme.
• Final SOPs Package: Finalised, validated SOPs incorporating all stakeholder feedback, together with the monitoring and supervision framework for ongoing SOP compliance.
• Activity and Progress Report: A consolidated report summarising all activities carried out throughout the assignment, key findings, challenges encountered, and recommendations for next steps.

5. Duration and Timeline

The assignment is estimated at approximately three (3) days per week and shall run from mid-July 2026 to September 2026, for an estimated total of approximately 30 working days. The exact number of working days shall be confirmed and mutually agreed upon before contract signature.

The indicative timeline is as follows:

Phase 1 — Inception and Needs Assessment ( July 2026)

• Submission of Inception Report

evaluate of existing SOPs, training materials, and guidelines documents

• perform key informant interviews with stakeholders at the national level and at the Quality Control Laboratory
• Needs Assessment Report and step by step to create/Update the existing SOPs and materials.

Phase 2 — SOP Development and Validation (August 2026)

• Development/ update the SOPs, and other related materials
• Facilitation of stakeholder evaluate and validation workshop
• Incorporation of feedback and finalisation of draft SOPs and other materials

Phase 3 — Capacity Development and Reporting (September 2026)

• Design and delivery of refresher training programme for target staff
• Development and submission of monitoring and supervision framework
• Submission of final Activity and Progress Report and handover of all documents to Sight and Life

Within seven (7) calendar days of contract signature, the consultant shall submit a detailed work plan specifying the schedule of activities, key milestones, and planned deliverable submission dates for approval by the Programme Manager.

6. Reporting and Supervision

The consultant shall report directly to the Africa Director and the Programme Manager of Sight and Life. Regular progress updates shall be shared on a bi-weekly basis, or at a frequency mutually agreed upon at the start of the assignment. All deliverables shall be submitted to the Programme Manager for evaluate and written approval before being considered final.

7. Qualifications and Experience

The ideal candidate will possess the following:

• Advanced degree in pharmacy, pharmaceutical sciences, analytical chemistry, quality assurance/quality control, public health, or a related field.
• Demonstrated experience in developing, reviewing, or updating SOPs, standard testing procedures, or operational guidelines for medicines quality control and laboratory testing.
• Strong knowledge of pharmaceutical quality control, laboratory testing and analytical methods, quality management systems with experience in Rwanda or the East African region strongly preferred.
• Prior experience working with or within the Rwanda Food and Drugs Authority (Rwanda FDA) or a similar regulatory authority or quality control laboratory is a strong advantage.
• Experience designing and facilitating quality control or laboratory capacity development or training programmes.
• Excellent facilitation, communication, and report-writing skills in English.
• Proficiency in Kinyarwanda is an asset.

8. Application Process

Interested candidates are invited to submit the following documents to Sight and Life:

• A motivation letter and an updated curriculum vitae (CV).
• A brief technical proposal (no more than three pages) outlining the proposed approach and methodology.
• A financial proposal indicating the daily consultancy rate.
• Contact details of two professional references.

9. Application Instruction

Qualified bidders are requested to submit their applications to SAL_Rwanda@sightandlife.org with the subject line: Consultancy for the Development of SOPs for In-House Quality Control for Health Commodities in Rwanda not later than July 10th at 6 PM Kigali time.

Please note that only short-listed bidders will be contacted. SAL Rwanda is an equal opportunity employer. All applications will be treated according to the merit of the candidate and with strict confidentiality.

Sight and Life reserves the right to accept or reject any application and is not bound to deliver reasons for its decision.