Quality Assurance of Reproductive Health Commodities
RHSC, SSWG, Addis Ababa, June 2011
Morten Sorensen, Deputy Chief,
Procurement Services Branch, Copenhagen
UNFPA
Because everyone counts
Enhancing the commodity
security of RH products
Role of Quality Assurance in Reproductive Health
Commodity Security
1. Implement quality assurance processes and
procedures that support procurement
2. Increase access to quality assured products and
manufacturers that meet internationally recognized
and specified quality standards and requirements
3. Adopt appropriate risk management strategies to
enhance availability of quality assured products
Quality Assurance system
Prequalification
Programme
Strengthening
QA systems
Capacity building
& partnerships
with MOH
UNFPA
Because everyone counts
• Identify manufacturers who meet WHO/UNFPA
prequalification standards
• Implement QA approaches/strategies that enable
procurement of quality assured products
• Advocate for the adoption and harmonization of
regulatory requirements and in-country quality testing
procedures that enhance access and availability of
quality RH commodities within countries
Quality Assurance
Policy for RH Medicines
Strengthening QA systems & procedures
Developed a QA policy for RH medicines
1. Limited number of prequalified RH products and
lack of risk management strategies
2. The need to adopt QA processes to minimize
quality risks
3. Continue collaboration with key partners (WHO &
other UN agencies) to implement the QA strategies
Prequalification of male
condoms & IUDs
Prequalification Programme
Prequalified
26 male condom factories
8 IUD factories
Total Number of Condom and IUD Factories
Inspected by Year
70
No. Factories
60
50
Condom Factories
40
IUD Factories
30
Total
20
10
0
2009
2008
2007
2006
2005
2004
2003
2002
2001
Year
1.
2.
Heavy on financial & human resources
Collaboration with partners and relevant stakeholders has been instrumental
UNFPA
Because everyone counts
New developments for
Female Condoms
 New product designs
 Various stages of
development
 Different materials
 Varying features:
 Insertion
 Retention
 Generic specifications,
prequalification &
procurement guidelines
 ISO standard
Supporting national systems
Capacity Building including effective partnerships &
collaborations
Quality Control Laboratories - Trained 21 countries in the Latin America &
Caribbean region on quality control laboratory testing standards for RH
commodities
1. Inconsistent quality testing methods and unclear regulatory
requirements
2. Promote adoption of international standards & WHO/UNFPA
guidelines and the harmonization of testing procedures and
laboratory management; clarity on regulatory and registration
requirements
3. Include participation of National Medicines Regulatory Authorities
and Ministry of Health to enhance availability & access to quality
assured products.
Updated guidelines
 Male Latex Condom specifications, prequalification
and procurement guidelines
 The TCu380A Intrauterine Contraceptive Device
specifications, prequalification and procurement
guidelines
 Statement on post-shipment testing of male
condoms
CD-rom (all publications in one)