Male latex condom: specification, prequalification and guidelines for procurement, 2010

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Chapter 5: Male latex condom prequalification scheme

In this chapter

1 Introduction
1.1 Background
1.2 Objectives
2 The Prequalification Scheme for male latex condoms
2.1 Eligibility to participate
2.2 Expression of Interest
2.2.1 Calls for and submission of Expressions of Interest
2.2.2 Assessment of documents submitted
2.2.2.1 Initial screening of documentation
2.2.2.2 Assessment of the Product Dossier and the Site Master File summary
2.3 Site inspection
2.3.1 Inspection team
2.3.2 Scope and scheduling
2.3.3 Transparency
2.4 Product testing
2.5 Reporting and communication of the results of the site inspection
2.6 Decision to prequalify
2.7 Listing of prequalified male latex condoms and manufacturing sites
2.8 Maintenance of the prequalification status
2.9 Periodic monitoring of product quality produced by prequalified manufacturing sites
2.10 Reassessment
2.11 Language
2.12 Fees
2.13 Resolution of disputes
3 Confidentiality undertaking
4 Conflict of interest

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