Quality Monitoring at different stages

Pre-shipment inspection, sampling and testing

For most categories of products, pre-shipment inspection and testing is not recommended. For certain categories of products, the implementation of pre-shipment inspection, sampling and testing activities may be required, as a risk mitigation measure rather than as a quality assurance mechanism.

Pre-shipment with randomized sampling and testing is required for the following product categories: Finished Pharmaceuticals Products (FPPs) recommended for procurement by the WHO Expert Review Panel (ERP); In-vitro Diagnostic Products recommended for procurement by the WHO ERP for Diagnostics (ERPD); Condoms (male and female) that are not listed in the UNFPA list; and all Vector Control products.

Post-shipment inspection, sampling and testing

UNDP COs must perform post-shipment inspection at the time of the reception of the goods by visual inspection and review of import documentation that the products received are in line with the purchase order and the specifications. UNDP GFPHST does not advise conducting routine post-shipment quality control testing, except if the information collected on transit and logistic conditions during the post-shipment inspection indicates the likelihood of a risk on the quality or the performance of the products procured.

In-country inspection, sampling and testing

In-country quality monitoring activities should consider a range of activities which are complementary to each other rather than relying on only one specific activity such as quality control testing. Activities include visual inspection of the packaging of the products focussing on reviewing the content of packaging and labelling such as spelling errors, inadequate reference to standards, expiry date.

Full quality control testing of the products is a time consuming, costly and lengthy procedure used to confirm the compliance of a product. This should be engaged using a risk-based approach or when there is already presumption of non-compliance to confirm any doubt on product quality or failure.

Detailed guidelines for in-country quality monitoring of health products can also be found in the following documents:

• Guide to Global Fund Policies on Procurement and Supply Management of Health Products, available here.
• Guidance on in-country quality monitoring of pharmaceutical products in Global Fund supported programs, available here.
• Global Fund information note on Quality Assurance Requirements for the Procurement of Masks and Respirators, available here.
• Global Fund Briefing Note on Quality Assurance Requirements for the Procurement of Oxygen Therapy Medical Devices, available here.
• Global Fund Briefing Note: Visual Inspection of Insecticide-treated Nets (ITNs), available here.
• Global Fund Briefing Note: Pre-Shipment Sampling, Testing and Reporting Results for Insecticide-treated Nets (ITNs), available here.
• Global Fund Briefing Note: Post-market surveillance of Insecticide-treated Nets (ITNs), available here.
• WHO Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics, available here.