Quality Assurance for Health Products

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Procurement
Innovation, CSO engagement
Quality Assurance for Health Products

Main navigation

Procurement Overview
Procurement Strategy and Planning
- Procurement Forecasting and Delivery
- Transactional Procurement Strategies and Procurement Planning
Requisition
- Requisition and Procurement of Goods, Civil Works and Services
Sourcing of Suppliers
- Sourcing and Market Research
- Vendor Sanctions
Procurement Methods
- Procurement Methods
Innovation, CSO engagement
Solicitation Process
Evaluation of Offers and Pre-award Negotiations
- Evaluation of Offers
- Pre-Award Negotiations
Procurement Review Committees
- Procurement Oversight and Procurement Review Committees
Award and Management of Contract
Construction Works
- Construction Works
Individual Contract
- Individual Contract
Long Term Agreements (LTAs) and Cooperation with UN Entities
- Long Term Agreements (LTAs) and Cooperation with UN Entities

Focal Point

Seloi Mogatle

Effective Date

02/07/2018

Planned Review Date

30/06/2024

Version

1.0

Latest updates

March 27, 2019 - The Quality Assurance Policy and Procedures for Health Products have been added to the Procurement section of the POPP. This new chapter is available under the Innovation, CSO engagement, and E-tendering policy area. It was developed to assure the safety of all health products procured by UNDP, in line with international best practices. By detailing UNDP quality assurance requirements for health procurement, the Policy represents a key document for all parties involved in procurement activities across UNDP as well as for national partners, suppliers and donors.

Policies

Main Policy

Quality Assurance for Health Products

DOCX (84.95 KB)

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Procedures

Main Procedures

1

Steps

When starting health procurement services for a government, business units doing health procurement in UNDP (e.g. COs, ROs, GPU Health, GF HIST Procurement Team) should ensure that health products supplied are compliant with the requirements of the UNDP QA Policy for health products.

Responsible Party

CO Director and Programme Manager,

Regional Offices,

PSU/GPU Health HDD/GF HIST Procurement team

Template/Guideline

Explanatory Notes

Quality Assurance Policy should be implemented by all business units doing health procurement (e.g. COs, ROs, GPU Health, GF HIST Procurement Team).

Introductory and regular trainings of UNDP staff involved in health procurement activities in COs, ROs and in Copenhagen will be conducted by QA Specialists of the GF HIST team to ensure full understanding and implementation of the Quality Assurance Policy.

2

Steps

If the procurement strategy defined is to do health procurement using the global procurement architecture (through global LTAs with manufacturers, suppliers or MoU with other UN agencies), the CO/RO will need to ensure procurement is done according to technical specifications/criteria defined in the LTAs/SLAs and, when required, should include the quality reference approved in the LTAs/SLA in the POs.

Responsible Party

CO or RO Procurement team,

GPU Health and GF HIST Procurement team,

With oversight of the GF HIST QA team

Template/Guideline

SOPs for using global LTAs/SLAs are regularly posted in the

UNDP Global Fund and Health Implementation manual

Explanatory Notes

GF HIST and GPU Health will ensure the SOPs are regularly updated on QA aspects in close collaboration with the GF HIST QA Team and shared with CO procurement colleagues and GF HIST QA team will guide them to implement the QA aspects.

The GF HIST QA team will review and clear all new procurement processes, based on category and related risks involved, in line with the QA policy and will validate new suppliers and conduct assessment of the manufacturing site and the product as required by the QA policy.

3

Steps

If the procurement strategy is to do health procurement (establishing LTAs or direct procurement) at CO level, the QA Team of the GF HIST team should be involved in reviewing the list of products to be supplied, in validating the QA criteria used to select sources and in tender documents, in assessing offers received and to validate the sources proposed before contracts are awarded.

Responsible Party

Programme Manager and CO/RO procurement teams,

GF HIST QA Team

Template/Guideline

Explanatory Notes

The project implementation should be carried out in close collaboration with GF HIST QA team.

4

Steps

All business units doing health procurement should keep track of the products supplied to governments (key documents: POs, delivery notes, certificate of analysis, and batch numbers) to able to justify the sources selected with National Regulatory Authorities and to facilitate recalls in case of a quality complaint.

Responsible Party

CO/RO Procurement teams,

GPU Health,

GF HIST Procurement team

Template/Guideline

Explanatory Notes

All business units doing health procurement should keep files with all documents related to products supplied (POs, delivery notes, certificate of analysis, and batch numbers).

5

Steps

Quality Control (QC) activities (testing of samples) are part of the general QA policy.

All QC activities initiated at CO level must be managed in accordance with the “Guidance for UNDP Country Offices on Health Products Quality Assurance in the Supply Chain”.

Any non-compliant QC results (Out of Specifications = OOS) should be reviewed under the supervision of the GF HIST QA team.

Responsible Party

CO/RO Procurement teams,

GF HIST QA Team,

GF HIST PSM Country focal points

Template/Guideline

Guidance for Country Offices on Health Products Quality Assurance in the Supply Chain is found in the

UNDP Global Fund and Health Implementation manual

Explanatory Notes

The second template for this step, “SOP on QC testing of health products” is forthcoming.

COs should share with the GF HIST team any non-conformed results found through Quality Control testing and follow the instructions from the GF HIST PSM team in how to interpret these results.

6

Steps

Any quality complaints should be reported to GF HIST Quality Assurance Team. Each case will be reviewed, and relevant instructions and guidance will be provided by GF HIST to Business Units doing health procurement ((e.g. COs, ROs, GPU Health, GF HIST Procurement Team).

Responsible Party

CO Procurement Team with copy to CO Management team,

GF HIST QA Team

Template/Guideline

Explanatory Notes

The template for this step, "SOP on how to handle a quality complaint", is forthcoming.

All quality related complaints should be carefully treated, since it may lead to a risk of reputational damage. The role of the CO is to collect information and to transfer it immediately to the GF HIST QA team and to follow the instructions given by the GF HIST QA team to handle the case (communication with national counterparts, with suppliers, with media).

7

Steps

Submission of an Annual Quality Assurance Report to the Associate Administrator.

Responsible Party

GF HIST QA Team

Template/Guideline

Explanatory Notes

In the UNDP QA Policy, it is agreed BPPS/HHD will submit an annual Quality Assurance Report to the Associate Administrator with copy to Regional Bureaux, Bureau of Management Services, and the Office of Audit and Investigations.

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