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Quality Control (QC) activities

As per the UNDP QA Policy, products purchased through UNDP must be tested according to a randomized sampling plan, which is based on a risk assessment by product category and by product. The GHSC QAS Team has issued guidance for Country Offices outlining 1) how to prepare a multi-year QC Plan including a template, and 2) how to prepare an annual Sampling Plan including a template and a calculation tool and instructions on how to use the tool.

The annual sampling plan should include the number of batches to be tested based on the annual procurement plan. Both random and targeted risk-based sampling is recommended at different points across the supply chain. The selection of batches to be tested should follow the recommendations in section VII of the Guidance for UNDP Country Offices on Health Products Quality Assurance in the Supply Chain.

The PR must implement the annual plan and must maintain a record of the test results. The test results must also be shared with the GHSC QAS team.

For FPPs and Diagnostics approved by the WHO ERP and procured with Global Fund grant resources, the Global Fund Secretariat is responsible for organizing and paying for the quality control of these products prior to their shipment. UNDP COs are responsible for notifying the Global Fund Secretariat of their intent to purchase such products – using the following forms pharmaceuticals, additional Order of ERP Pharmaceutical Products, and diagnostics – and must receive a “no objection letter” (NOL) before confirming the purchase order. The NOL must be provided to the GHSC HPS and QAS teams before the PO can be issued.

Once the products are ready for sampling, the manufacturer informs the Global Fund who organizes the sampling and testing by a third-party laboratory contracted by the Global Fund. Upon receipt of a successful test results, the Global Fund will issue the final letter, including the test report, to the PR and the manufacturer, authorizing the product shipment. This letter must also be provided to the GHSC QAS team for their records.

For pharmaceuticals, other than ERP products, UNDP has established LTAs with Quality Control laboratories that are WHO prequalified for the provision of sampling and testing of pharmaceuticals. LTAs for pre-shipment inspection and for QC laboratories for sampling and testing of other product categories are being established and should be available during semester 2 of 2024.

Additional guidance to support this area of work are also available through resources listed below:

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