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Quality Assurance

Access to safe and effective hormonal contraceptives, contraceptive devices, medicines, and equipment is absolutely essential to ensuring reproductive health (RH). UNFPA is committed to procuring high quality (RH) products and therefore evaluates and prequalifies suppliers based on internationally recognized quality standards before entering into any contractual agreements.

UNFPA Quality Assurance activities follow a systematic process to ensure that RH products meet specified requirements and standards. Quality assurance activities include prequalification, technical evaluations, quality control, and monitoring. Quality control refers to a set of activities to determine whether the specified standards are being maintained through inspection, sampling, and laboratory testing. Please refer to the UNFPA Quality Assurance Framework for detailed information on Quality Assurance.

UNFPA procures a range of quality assured RH commodities including male condoms, female condoms, IUDs, medical devices & equipment, hormonal contraceptives, and medicines to support Maternal Health and Sexual & Reproductive Health.
 

Medicines

The UNFPA Quality Assurance system has been harmonized with UN partner agencies. Following international quality standards and supported by WHO and other organizations, UNFPA has defined a Quality Assurance policy for hormonal contraceptives and other medicines, where highest importance is given to the Pre-qualification process. Additionally, to prevent an interrupted supply of the medicines that are under the WHO Prequalification Programme, an interim process called the Expert Review Panel (ERP) is available, where less than three pre-qualified products are available. The ERP is an alternative to the quality assessment for those manufacturers that are on their way to pre-qualification but have not yet achieved this status. Results of the latest ERP process conducted are publicly available.  A new Expression of  Interest for the ERP Process was published in April 2017.

For medicines that do not appear on the ERP reviewed list, UNFPA may allow procurement provided a Notification Form has been completed by the procurer and approved by the Quality Assurance team. 

For all other procured medicines not under WHO Prequalification or ERP assessment, in accordance with good practices, UNFPA will evaluate and implement quality control measures. This quality evaluation will be based on GMP compliance as well as applicable technical documentation as reviewed and approved by the internal technical committee.
 

Medical Devices

Medical devices and equipment play an important role in the screening, prevention, treatment and management of illnesses, diseases and health interventions. UNFPA values the importance of quality in each and all the medical devices and equipment that it procures. UNFPA, therefore, follows recommendations on standards and quality systems for medical devices set by the World Health Organization (WHO) and the International Medical Devices Regulatory Framework (IMRDF) - formerly performed by the Global Harmonization Task Force. 

The overall goal is to prevent the supply and use of substandard devices and equipment to safeguard public health and safety. More specifically, the role that procurement plays is ensuring that effective, safe and quality products are supplied to healthcare facilities at all levels of the health care system.

UNFPA Procurement Services Branch has a separate team dedicated exclusively to Quality Assurance matters. By this segregation, objectivity during bidding exercises is assured. For further information and any questions related to quality assurance in UNFPA procurement, please contact:

 

Quality Assurance team
UNFPA Procurement Services Branch
procurement@unfpa.org

For quality complaints of RH commodities procured by UNFPA, please submit this Quality Complaint Report Form (EnglishFrench)

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Policies


 

QA framework

 

QA Policy

 

Post-Shipment Testing

 

Waste Management

 

Model QA System