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.
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 here.
Below is list of recent Expression of Interest:
- 15th invitation to manufacturers of reproductive health medicines to submit an Expression of Interest (EOI) for product evaluation
- 14th invitation to manufacturers for Expression of Interest (EOI) regarding Reproductive Health medicines.
- 13th invitation to manufacturers for Expression of Interest (EOI) regarding ERP process was published on October 2017
- 12th invitation to manufacturers for Expression of Interest (EOI) regarding ERP process was published on September 2017
- 10th Invitation to Manufactures of Reproductive Health Medicines
- 7th Invitation to Manufacturers of Reproductive Health Medicines
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 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 firstname.lastname@example.org.
As part of its commitment to ensuring that all individuals have access to affordable, quality-assured reproductive health and family planning supplies, UNFPA Procurement Services Branch offers procurement capacity building in the form of technical support, training, and mentoring activities for key stakeholders in the production and regulation of RH commodities. This capacity building is available to manufacturers, national regulatory authorities, national quality control laboratories, and other similar bodies. Current capacity building initiatives include:
- Regional workshops on standards and laboratory quality control for RH products
- On-site trainings for national laboratories testing male and female condoms as described here
- In collaboration with WHO, informational annual meeting on the WHO/UNFPA prequalification processes and specifications
- Regional hands-on training on male condom dossier assessment
- Male condom inspection
UNFPA is also available to provide Quality Assurance Capacity Building support for third-party organizations upon request.
Third party support includes consultation on quality assurance issues, training, and policy development.
For information on upcoming capacity building workshops and events please contact the Quality Assurance team.