Functional Areas
- Functional Areas
- Legal Framework
- Project Document
- The Grant Agreement
- UNDP-Global Fund Grant Regulations
- Grant Confirmation
- Grant Confirmation: Face Sheet
- Grant Confirmation: Conditions
- Grant Confirmation: Conditions Precedent (CP)
- Grant Confirmation: Special Conditions (SCs)
- Grant Confirmation: Limited Liability Clause
- Grant Confirmation: Schedule 1, Integrated Grant Description
- Grant Confirmation: Schedule 1, Performance Framework
- Grant Confirmation: Schedule 1, Summary Budget
- Implementation Letters and Performance Letters
- Agreements with Sub-recipients
- Agreements with Sub-sub-recipients
- Signing Legal Agreements and Requests for Disbursement
- Language of the Grant Agreement and other Legal Instruments
- Amending Legal Agreements
- Other Legal and Implementation Considerations
- Legal Framework for Other UNDP Support Roles
- Health Product Management
- Sub-recipient Management
- Capacity Development
- Interim Principal Recipient of Global Fund Grants
- A Strategic Approach to Capacity Development
- Resilience and Sustainability
- Legal and Policy Enabling Environment
- Functional Capacities
- Capacity Development and Transition
- Transition
- Capacity Development Objectives and Transition Milestones
- Capacity Development Results – Evidence From Country Experiences
- Capacity development and Transition Planning Process
- Capacity Development and Transition – Lessons Learned
- Risk Management
- Audit and Investigations
- Human Rights, key Populations and Gender
- Human Resources
- Legal Framework
Quality Monitoring at different stages
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.
Resources
Functional Area: Health Product Management Project Stage: Grant Implementation Author: The Global Fund Language: English Type: Policies, Procedures and guidance Topic: Procurement and Supply Management, Global Fund Procurement Policy Resource File Format: PDF Resource Accessibility: Publicly accessible
Guidance on in-country quality monitoring of pharmaceutical products in Global Fund supported programs Download
Functional Area: Health Product Management Project Stage: Grant Implementation Author: The Global Fund Language: English Type: Policies, Procedures and guidance Topic: Quality Monitoring at different stages, Quality Assurance (QA), sampling and testing, In-country inspection Resource File Format: PDF Resource Accessibility: Publicly accessible
Global Fund information note on Quality Assurance Requirements for the Procurement of Masks and Respirators Download
Functional Area: Health Product Management Project Stage: Grant Implementation Author: The Global Fund Language: English Type: Policies, Procedures and guidance Topic: Masks and Respirators, Quality Monitoring, In-country inspection Resource File Format: PDF Resource Accessibility: Publicly accessible
Functional Area: Health Product Management Project Stage: Grant Implementation Author: The Global Fund Language: English Type: Policies, Procedures and guidance Topic: sampling and testing, Quality Monitoring , Inspection of Insecticide-treated Nets, ITNs Resource File Format: PDF Resource Accessibility: Publicly accessible
Global Fund Briefing Note: Pre-Shipment Sampling, Testing and Reporting Results for Insecticide-treated Nets (ITNs) Download
Functional Area: Health Product Management Project Stage: Grant Implementation Author: The Global Fund Language: English Type: Policies, Procedures and guidance Topic: In-country inspection, Quality Monitoring , sampling and testing, Pre-Shipment Sampling Resource File Format: PDF Resource Accessibility: Publicly accessible
WHO Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
Functional Area: Health Product Management Project Stage: Grant Implementation Author: WHO Language: English Type: Policies, Procedures and guidance Topic: vitro diagnostics, surveillance of medical devices, Quality Monitoring , In-country inspection, post-market surveillance Resource File Format: Link Resource Accessibility: Publicly accessible
Briefing Note on Quality Assurance Requirements for the Procurement of Oxygen Therapy Medical Devices Download
Functional Area: Health Product Management Project Stage: Grant Implementation Author: The Global Fund Language: English Type: Policies, Procedures and guidance Topic: Quality Monitoring , sampling and testing, In-country inspection, Oxygen Therapy Medical Devices Resource File Format: PDF Resource Accessibility: Publicly accessible
Functional Area: Health Product Management Project Stage: Grant Implementation Author: The Global Fund Language: English Type: Policies, Procedures and guidance Topic: Quality Monitoring , In-country inspection, Insecticide-treated Nets, Post-market Surveillance Resource File Format: PDF Resource Accessibility: Publicly accessible