Quality Assurance for Health Products

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Procurement
Innovation, CSO engagement
Quality Assurance for Health Products

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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
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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

01/09/2024

Planned Review Date

01/09/2027

Version

2.0

Latest updates

September 02, 2024 -

The revised Quality Assurance for Health policy and procedures result from valuable lessons learned from implementing the 2018 policy version during the height of the COVID-19 pandemic. It serves to assure the safety of all health products procured by UNDP, in line with international best practices. The significant changes in the revised policy include the following:

1. &

September 02, 2024 -

The revised Quality Assurance for Health policy and procedures result from valuable lessons learned from implementing the 2018 policy version during the height of the COVID-19 pandemic. It serves to assure the safety of all health products procured by UNDP, in line with international best practices. The significant changes in the revised policy include the following:

1.    Requirements for PPE, in-vitro diagnostics, and medical gas systems.
2.    Recognition of market clearances and manufacturer certificates issued by Conformity Assessment Bodies that are members of the International Accreditation Forum for Class A medical devices.
3.    Roles and responsibilities of the UNDP QA in CO/RBx managed procurement
4.    Establish a committee to conduct risk-benefit assessments of health products in complex situations.
4.    Recognition of QA approvals made by other UN agencies and other international organisations.
5.    Requirements for emergency assessments and approvals in response to pandemics declared by WHO and levels of crises declared by UNDP.
5.    Clarifies requirements for the use of Research Use Only products used in medical laboratory settings.
6.    Recognition of health product market authorisation and other regulatory activities of WHO Listed National Regulatory Authorities.
7.    Recognition of health product market authorisation and other regulatory activities of National Regulatory Authorities with WHO maturity Level 3 and 4 in specific conditions.

March 27, 2019 -

The Quality Assurance for Health Products policy and the Quality Assurance for Health Products procedures have been added to the Procurement policy area of the POPP. This new policy page is available under the Innovation, CSO Engagement policy chapter. 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.

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Policies

Main Policy

Quality Assurance for Health Products

DOCX (202.2 KB)

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Procedures

Main Procedures

1

Step

Before starting health procurement services for a government, Business Units (BU) (e.g. COs, RBx, GPSD-Health) should be aware of the UNDP QA Policy for health products and inform the partners of the need to comply with the Policy. The BU should seek guidance from the QA team to ensure that the health products to be supplied will comply with the requirements of the UNDP QA Policy for health products.

Responsible Party

CO Director and Programme Manager,

RBx,

GPSD-Health

Template/Guideline

Explanatory Notes

Quality Assurance Policy should be implemented by all business units doing health procurement (e.g., COs, RBxs, GPSD-Health).

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

2

Step

If the procurement strategy defined is to do health procurement using the global procurement architecture, the COs/RBx engages the services of GPSD-Health. In this case, the GPSD-Health must engage the services of the QA Team as outlined in 4 below

Responsible Party

CO or RBx Procurement team,

GPSD-Health

Template/Guideline

Explanatory Notes

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

The UNDP 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

Step

In case local procurement is justified, the BU must engage the services of the QA Team as per step 4. The QA Team should be engaged before the procurement starts to facilitate smooth QA process.

Responsible Party

CO,

RBx,

UNDP QA Team

Template/Guideline

Explanatory Notes

The project implementation should be carried out in close collaboration with UNDP QA CO.

4

Step

QA services in a procurement process: The UNDP QA Team must be involved to review the list of products to be supplied, develop technical TORs (including review of technical specifications), in developing the QA criteria used in solicitation documents to select the products and sources, in evaluating technical offers received and to approve the products and sources before contracts are awarded.

Responsible Party

UNDP QA Team

Template/Guideline

Explanatory Notes

UNDP QA Team will follow relevant SOPs to ensure the Technical TORs of the solicitation documents include the technical and regulatory requirements and that the products to be procures comply (technical and regulatory) with UNDP QA Policy.

5

Step

All business units should maintain a record of the health’ products supplied to governments/partners (key documents: POs, delivery notes, certificate of analysis, and batch numbers) and details of suppliers to justify the sources selected with National Regulatory Authorities and to facilitate recalls, handling quality alerts or quality complaint.

Responsible Party

CO/RBx Procurement teams GPSD-Health team,

GPSD-Health team

Template/Guideline

Explanatory Notes

All business units doing health procurement should keep files with all documents related to:
1. Products supplied (POs, delivery notes, certificate of analysis, and batch numbers).
2. Suppliers – regulatory certificates/approvals, contact details, supplier master file etc.

6

Step

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 UNDP QA team.

Responsible Party

CO/RBx Procurement teams,

UNDP QA Team,

GFPHST PSM Country focal points

Template/Guideline

Explanatory Notes

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

COs should share with UNDP QA team any non-conformed results found through Quality Control testing and follow the instructions on how to interpret these results.

7

Step

Any quality complaints, quality alerts, recalls should be reported to UNDP QA Team. Each case will be reviewed, and relevant instructions and guidance will be provided by UNDP QA Team to BU doing health procurement (e.g. COs, RBx, GPSD-Health).

Responsible Party

Procuring entity e,g, GPSD-Health, CO, RBs,

Suppliers UNDP QA Team

Template/Guideline

Explanatory Notes

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 UNDP QA team and to follow the instructions given by the UNDP QA team to handle the case (communication with national counterparts, with suppliers, with media).

8

Step

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

Responsible Party

UNDP QA Team

Template/Guideline

Explanatory Notes

In the UNDP QA Policy, it is agreed BPPS/HHG 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.

United Nations
Development Programme

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