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)