UNFPABecause everyone counts
Quality Assurance of Reproductive Health
CommoditiesRHSC, SSWG, Addis Ababa,
June 2011Morten Sorensen, Deputy
Chief, Procurement Services Branch,
Copenhagen
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
•Identify manufacturers who meet WHO/UNFPA prequalification standards
Prequalification Programme
•Implement QA approaches/strategies that enable procurement of quality assured products
Strengthening QA systems
•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
Capacity building &
partnerships with MOH
UNFPABecause everyone counts
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
1. Heavy on financial & human resources
2. Collaboration with partners and relevant stakeholders has been instrumental
UNFPABecause everyone counts
Total Number of Condom and IUD Factories Inspected by Year
0
10
20
30
40
50
60
70
2001
2002
2003
2004
2005
2006
2007
2008
2009
Year
No. Facto
rie
s
Condom Factories
IUD Factories
Total
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)
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