UNFPA
Because everyone counts
UNFPA Update
IPC meeting December 2015, Geneva
Procurement Services Branch, Copenhagen
UNFPA Update
1.
2.
3.
4.
5.
6.
ERP
Training of National Procurement Agencies
Thermal cycling study - Oxytocin
Contraceptive devices and lubricants
Generic Hormonal Medicines uptake
Eco Requirements for UNFPA Supplies
UNFPA
Because everyone counts
1. UNFPA ERP for RH
Pharmaceutical Products
 Products
 Since 2011 –
 8 EOIs published
 Challenges
 For some product categories: still not enough that are WHO PQed



Injectable hormonal contraceptives – DMPA
Oxytocin
Mifepristone
 For some product categories: none WHO PQed

Magnesium sulphate
 Uptake of Generic RH medicines – Hormones
2. Training of National Procurement
Agencies
 E-learning Modules
 Good Governance of Medicines – in collaboration with WHO
 Introduction to Quality Assurance of Reproductive Health Medicines
 English/French/Spanish
http://portals.unssc.org/course/index.php?categoryid=8
 In-country procurement trainings
 2 weeks training
 1-2 days dedicated to QA
 Institutionalisation of the training
3. Thermal Cycling Study - Oxytocin
 Study Objectives
 Primary aim
 simulate interruptions in cold-chain storage of oxytocin by cycling storage
temperatures of ampoules to various levels and for varying durations, and
 determine the effects of these excursions on the active content of oxytocin
10 IU/mL ampoules.
 Secondary aim
 a qualitative analysis of possible known degradants will be undertaken
 further qualitative investigations using a separate assay may be performed
on any samples that fall below 90% of expected oxytocin levels during the
study, in order to investigate possible degradation pathways that have
resulted from temperature excursions.
UNFPA
Because everyone counts
3. Thermal Cycling Study - Oxytocin
 Study Objectives
 Primary aim
 simulate interruptions in cold-chain storage of oxytocin by
cycling storage temperatures of ampoules to various levels
 for varying durations, and
 determine the effects of these excursions on the active content of
oxytocin 10 IU/mL ampoules.
 Secondary aim

 a qualitative analysis of possible known degradants will be undertaken
 qualitative investigations using a separate assay may be performed on any
samples that fall below 90% of expected oxytocin levels during the study, in
order to investigate possible degradation pathways that have resulted from
temperature excursions.
UNFPA
Because everyone counts
3. Thermal Cycling Study - Oxytocin
Temp
Storage period and conditions
Day 1 – 30
Day 31 –
45
Day 46 –
75
Day 76 –
90
Day 91120
Storage at
Elevated
Temperat
ure
Storage at
2-8°C
Storage at
Elevated
Temperat
ure
Storage at
2-8°C
Storage at
Elevated
Temperat
ure
Day 30
Day 45
Day 75
Day 90
Day 120
30°C
40°C
50°C
Analy
sis
day
UNFPA
Because everyone counts
3. Thermal Cycling Study - Oxytocin
 Samples
 Three manufacturers – three batches each
 Transported under cold-chain from supplier to Monash University
 Analysis
 LC-MS-MS
 Partnership Facilitated by FIP
UNFPA
Because everyone counts
4. Contraceptive devices
 Review and update of TCu380A IUD Specification and Prequalification
Guidelines: on-going
 Specification update d and usability enhanced
 Additional guidance on stability studies, sterility assurance, and QA
monitoring by procurers added
 Review and update of WHO/UNFPA Male Latex Condom Specification
and Prequalification Guideline initiated
 Updated list of WHO/UNFPA Prequalified contraceptive devices
available on line (male condoms, female condoms , IUDs)
 Lubricants – completed systematic review completed which will feed
into development of technical specifications - Urgently needed to
support sex workers
5. Generic uptake:
AccessRH online catalogue
 Procurement planning tool - Now gives prominence to
INNs
 Progress: procurement value of generic
 Gain value for money: The significant volume of
contraceptives and related items procured by UNFPA
allows for competitive pricing. UNFPA passes these savings
on to partners via AccessRH
UNFPA
Because everyone counts
5. Generic uptake
UNFPA
Because everyone counts
6. New eco-requirements for
UNFPA/WHO supplies
 Beginning in 2015, UNFPA tenders will require potential suppliers to
comply with 5 eco-requirements:
 ISO 14001 certified – If a factory does not have ISO 14001 certification, it
must agree to work on obtaining it within the next 36 months.
 Wastewater treatment plan – The factory must comply with local laws
regarding wastewater treatment and discharge. It must also demonstrate
that any resulting sludge or solid waste is disposed of according to local
regulations. The factory should analyse its wastewater handling system
and prioritize and create a plan for improving the treatment of wastewater
where practicable.
7. New eco-requirements for
UNFPA/WHO supplies contd.
 Air pollution reduction plan – The factory must comply with local
laws regarding air pollution.
 Plan for saving energy and using renewable energy – The factory
must document a long-term plan for saving energy and using
renewable energy, and demonstrate any recent energy-saving
developments. Some bonus points will be awarded to factories using
renewable energy.
 Packaging:
– All cardboard and outer boxes must be FSC or equivalent (sustainable forestry)
–
–
The outer box and shipping box must be made of minimum 40% by 2016.
The gross box should only contain paper/cardboard.
– The plastic carton liner should be made from recycled material/plastic by 2015 and
biodegradable plastic by 2020.
UNFPA
Because everyone counts
Thank you