The prequalification process by QT6Fh1nm


									                      The Prequalification Process – Step by Step
                     For Male Latex Condoms, Female Condoms and IUDS

Consistent with WHO/ISO procedures, the prequalification process contains the
following steps:

1. Submission of Expression of Interest (EOI)
     Covering letter, in English, expressing interest in participating in the Prequalification
      Scheme and confirming that the information submitted in the Product Dossier and Site
      Master File is true and correct.
     Product dossier, in English, submitting product data and information.
     A Site Master File, in English, for each manufacturing site listed in the product dossier.
     Quality Manual.
     Copies of all market licenses; ISO and Quality Certifications.
     Ten samples of each product in its final packaging to enable visual inspection of the
      product, the packaging materials and the label.

2. On-Site Factory Inspection

A two day inspection of the production site will be performed by a team of inspectors,
consisting of experts appointed by UNFPA who will act as temporary advisers to
UNFPA. The scope of the audit will be focused on all below listed aspects related to the
production process at factory site, including verification of Quality Management Systems. This
includes, but is not limited to:
     Factory corporate structure including selection of key staff, training and responsibilities
     Products manufactured and annual production capacity
     Origins of production technology
     Raw materials selection, storage and quality
     Production operation and control
     Testing operation and control
     Final packing
     Quality control after processing operation
     Batch traceability
     Laboratory facilities, competence and calibration
     Factory infrastructure, maintenance and warehousing conditions
     Outgoing product quality and handling of condom failure
     Sampling and testing of products in accordance with ISO 25841 – 1
     Testing of products in accordance with ISO 4074:2002 and ISO 7439
      Compliance with the WHO/UNFPA Specifications for Male condoms, Female Condoms
       or IUDs covering:
           o General Requirements
           o Performance Requirements
           o Design Requirements
           o Packaging Requirements
           o Compliance Testing

3. Outcome of the Prequalification Process
After completion of the on-site factory inspection, the inspection team along with
UNFPA, will assess the evidence and findings collected during the inspection and will decide
accordingly whether the manufacturer is eligible to be prequalified or not.
Based on this assessment UNFPA will either:
     Prequalify the commodity manufactured at a specific site without conditions.
     Require the manufacturer, where deemed necessary, to undertake specified
     corrective action(s).
     Determine that a manufacturing site is ineligible for prequalification (without any
        requirement for corrective action being offered).

4. The Continuity of the Prequalification Process: Re-Inspections
All UNFPA prequalified manufacturers will have to undergo a reassessment at intervals
of no more than three years. Such reassessments will consist of a comprehensive
evaluation of documentation, site inspection and product testing similar to the initial
prequalification assessment.

5. Resources

For detailed information regarding the prequalification process please refer to the following

Male Latex Condoms: Specification, Prequalification and Guidelines for Procurement, 2010

IUD: Specification, Prequalification and Guidelines for Procurememt, 2012

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