E-DRUG: Consultant: Development of Guidelines for Procurement of Reproductive Health Medicines
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Request for quotation: Call for Expression of Interest - Consultant for
Development of Guidelines for Procurement of Reproductive Health Medicines
United Nations Population Fund
Reproductive health (RH) medicines include hormonal contraceptives,
medicines for sexually transmitted diseases and medicines for maternal
health. UNFPA has been procuring RH medicines for over 40 years. Since the
early 1990s quality of RH medicines has been an important issue in
procurement of RH medicines. As a leader in procurement of RH medicines,
the UNFPA approved a Quality Assurance Policy for RH medicines in 2011.
This policy provides a high level commitment of UNFPA to procurement of
medicines of internationally accepted quality standards. The policy has
been implemented since its approval; however, there is need to
operationalize the policy by providing clear guidelines on various aspects
to assist procurers and governments. The main objective of these practical
guidelines is to ensure that only good quality RH medicines are procured
and distributed to those who need them. Therefore, UNFPA is calling for
submissions of proposal to develop the Guidelines for Procurement of RH
medicines.
Full information can be found on UNGM:
https://www.ungm.org/Public/Notice/25300
Development of Guideline for Procurement of RH medicines Terms of Reference
(ToR)
1. Develop a guideline for procurement of RH medicines addressing
the following key issues
a. Selection of medicines - definition of the medicines included in
the RH medicines to which the guidelines will refer to. This will be based
on the Essential Medicines List, taking into account the list of medicines
selected by UNFPA in order to fulfil its mandate, being UNFPA the lead
agency in the Reproductive Health field.
b. Quality Assurance systems for RH procurers - this system will be
based on the Model Quality Assurance system for procurement agencies (WHO
TRS 937) and its updates. A section of risk management with respect to
quality of RH medicines in procurement will be included.
i. Assessment of quality, safety and efficacy of medicines - For medicines
that are not eligible to WHO prequalification, there is still the need for
procurers to assess the quality, safety and efficacy. Hence, the procurers
use the inter-agency pharmaceutical product questionnaire or a modified
version of this questionnaire. There is need to clearly describe how the
assessment is to be performed, including supporting documents as criteria
used, assessment template etc. and provide supporting WHO or other
internationally acceptable standards.
ii. Inspection of manufacturers - For medicines that are not eligible to WHO
prequalification, there is a need for procurers to assess the quality and
safety of these medicines. Guidance on how to prioritise (risk based) GMP
inspections is required. There is also a need to provide additional
guidance on the critical procedures related to GMP inspection, including
SOPs to implement them.
c. Inspection of procurers/wholesalers - some procurement agencies
rely on private wholesalers for distribution and may or may not rely on
these wholesalers for some level of quality management system of RH
medicines. Guidance on how to judge the compliance of the distributors to
international quality standards needs to be provided.
d. Quality Control
i. General Requirements
ii. Sampling guidance
iii. Laboratories - requirements for laboratories that could produce
internationally acceptable analytical results. Include specifications that
procurement agencies may use to develop technical part of bidding documents
when requesting for laboratories.
iv. Pre-shipment inspection- Definition of a system of inspection with
supporting forms and procedures.
v. Pre-shipment testing - usually performed by independent laboratory on
request by procurement agency. A system for testing which includes risk
based selection of which analytical tests will need to be performed and the
frequency.
vi. Post-shipment testing - in some cases the procurement agency may conduct
post-shipments testing. In other cases this is done by the recipient (it
could be another international procuring agency or a national procuring
agency).
vii. Management of out of specifications - all levels of procurement.
e. Pharmacovigilance - how safety is monitored, role of regulatory
agency, role of procurement agency.
f. Labelling - minimum information required. Other types of
specifications for labelling e.g. withstand high temperatures and humidity.
g. Packaging - including shipping packaging requirements.
h. Storage - storage and shipment guidance in order to assure
maintenance of quality throughout the supply chain.
2. Method of Work
Desk research - primary and secondary sources.
Review and critique of current guidance documents on procurement
of medicines (in general, not just RH medicines).
Discussion with UNFPA team.
Participation in stakeholder consultation.
3. Expected Outcomes and Deliverables
A Guideline document in Word covering the sections as stated in the
TOR written in good scientific English with adequate illustrations, tables
and figures to assist the reader in understanding the document. All
references should be cited in a standard manner.
The guidance document excluding references should not exceed 50
pages.
Ms. Isabel Lucas Manzano
Pharmacist, Quality Assurance, Procurement Services Branch
United Nations Population Fund
Copenhagen, Denmark
+45 4533 7274
www.unfpa.org<http://www.unfpa.org/>, www.myaccessrh.org<
http://www.myaccessrh.org/>
Isabel Lucas Manzano <ilucasmanzano@gmail.com>