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

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Chapter 6: Operational guidance—male latex condom WHO/UNFPA prequalification scheme

In this chapter

1 Introduction
1.1 Invitation for Expression of Interest
1.2 Data and information to be submitted
1.3 Process for submitting documentation
1.4 Sample of the letter of application
1.5 Assessment of documents submitted
2 Preparation of a Product Dossier
2.1 Characteristics of the products
2.2 Samples
2.3 Local, country and regional regulatory approvals for the products
2.4 Raw materials
2.5 Supplier(s)
2.6 Sites of manufacture
2.7 Risk management of the product
2.8 Specifications for the finished products
2.9 Evidence of compliance with WHO/UNFPA’s General Requirements
2.10 Stability data
2.11 Labelling and additional information
3 Preparation of a Site Master File summary
3.1 General information
3.2 Manufacturing certifications
3.3 Personnel
3.4 Premises and equipment
3.5 Documentation
3.6 Records
3.7 Production
3.8 Risk management plan
3.9 Quality control
3.10 Distribution, complaints and product recall
3.11 Self-inspection (internal audits)
3.12 Corrective and preventive action
3.13 Design and development
4 Scope of manufacturing site inspections
5 Product testing
Table 8. Inspection guide

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