Pre-bid Conference

Micronutrient Powders (MNPs)

27 April 2017

Pre-bid Conference: Micronutrient Powders (MNPs)

AGENDA

(1) Background on MNPs

(2) Procurement history and Procurement process

(3) Procurement objectives

(4) Technical specification of the product

(5) Documents required for the Technical Assessment

(6) Requirements for manufacturing sites

(7) Q&A – please type your questions during the session

Jan Debyser, Alison Fleet, Dimitris Catsoulacos

UNICEF Supply Division

27/04/2017

Agenda

Micronutrient Powders (MNPs)

• Multiple micronutrient

powders (MNP) are an

innovation in point-of-use

fortification, addressing

vitamin and mineral

deficiencies.

• MNPs contain a blend of 5 or

15 vitamins and minerals in a

1 gram sachet, which are

easily sprinkled onto foods

prepared in the home.

What are they?

Food Fortification and Historical

Development of MNPs

• MNP was initially developed as a way to provide iron

and other nutrients required for the treatment of

anemia

• MNPs have now been recommended as a strategy to

improve the quality of complementary foods (for

children 6-24 months) to fill the micronutrient gaps

and not just as a method of anemia prevention and

treatment. MNPs are being integrated more in infant

and young child feeding programmes in the countries.

• With the expansion of use into preventive public health

programs, WFP, UNICEF and other organizations now

promote the use of formulations with additional

micronutrients

Issues and Concerns with MNPs

• Compliance - Children under five years of age,

may not be able to consume large enough

quantities of the fortified food to satisfy an

adequate level of their daily requirements

• Children do not like the ‘speckled’ look in their

rice or porridge

• Children are sensitive to the taste of the

components of the MNPs (vitamin C, iron, copper,

zinc)

• Product stability over time – powders are

susceptible to degradation as they are

hygroscopic

How do we procure MNPs?

• UNICEF Supply Division purchase MNPs for all

UNICEF country programmes implementing home

or point-of-use fortification programmes

• UNICEF Supply Division also offers Procurement

Services to any interested not-for profit partners or

national governments

Procurement Principles

• Nutrition products must be procured through

Supply Division only

• All procurement is done in a form of

competitive bidding

• Contracts are established based on lowest

acceptable offers

• To cover continuous demand Long Term

Arrangements (LTA) for 2-3 years period are

issued followed by individual Purchase

Orders

Procurement history (1)

• Started to purchase in 2007

• Exponential increase over the last 10 years

(1,188 M sachets in 2016)

0

200

400

600

800

1,000

1,200

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Mill

ion

sac

het

s

Product Demand

5 component - local layout 15 component - local layout 15 component - standard layout

Procurement history (2)

• Increase in countries ordering product

• 10 countries with highest demand in the last 5

years: Peru, Nepal, Myanmar, DRC, Mozambique,

Syria, Rwanda, Malawi, Pakistan, Afghanistan

8

1612

2024

33 34

41

48 47

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Number of countries ordering MNPs

Ordering countries

Procurement history (3)

• LTAs in place with 5 suppliers

• Current LTAs valid since July 2014

-

5

10

15

20

25

30

35

40

2012 2013 2014 2015 2016

Mill

ion

s

Number of packs procured

DAP CPH warehouse FCA point of departure

Procurement history (4)

• Customized layout for better compliance

• Gradual shift with now 2/3 customized

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Micronutrient Powder Demand by Layouts Type

Standard layout Customised layout

Procurement goals and objectives

Support further scale up of point-of-use

fortification programmes by suppling good quality

and fit for purpose MNPs for use in UNICEF

programmes and by partners, in sufficient

quantities, at competitive prices and when

required.

Procurement goals and objectives (2)

• Uninterrupted supply that meets specifications

• Manufacturers with capacity and flexibility to

absorb spikes in demand and need for

customization

• Opportunities for more sustainability (on-

continent production, waste generation, ..)

• Establish time-bound 6-7 LTAs for July 2017 –

July 2019 (2020) with multiple manufacturers

Forecast

• 60 million packs for 2 years (1,800 million

sachets)

• $30 - 35 million for 2 years

Solicitation method

• Request for Proposals

• Bid document will consist of:

– Invitation letter

– Bid Form (Validity of the offer, Currency and

Payment terms)

– Product specifications and quantities

– Forms to input unit prices, lead times …

– Contractual provisions (LTA text)

– Technical Requirements

– Instructions to bidders

– General Terms and Conditions

Financial offer (1)

• Unit price for box/pouch of 30x1g sachets– MNP-5 and/or MNP-15

– DAP Copenhagen warehouse and/or FCA Port/Airport of departure

– Standard layout (MNP-15 only) and/or customized packaging (MNP-5 and MNP-15)

• Currency– US$ or EUR

• Payment terms– 30 days net

– early payment discount

Financial offer (2)

• Production capacity:– capacity of the blending site

– capacity of the packing site

– allocated capacity to UNICEF

• Financial offers need to be submitted on time and according to instructions, even if more time is allowed for technical compliance

Timelines

• Request for Expression of Interest (March 2017)

• Invitee list (April)

• Pre-bid conference (27 April 2017)

• Summary of webinars circulated (early May)

• Issue Request for Proposal (early May)

• Bid closure (3 weeks after issuing RFP) – no public

opening

• Bid evaluation and adjudication (June)

• Presentation to Contract Review Committee (end

June)

• Creating LTAs (July)

Bids Submission

• Bids shall be submitted in response to the RFP

by email to supplybid@unicef.org (instructions

to follow in RFP invitation)

• Technical documentation shall be submitted in

an electronic form to One Drive supplier file

(instructions to follow in RFP invitation)

UNICEF Product Requirements

• Fine, off white odorless powder (with tiny

specks)

• Bland taste

• Does not impact on the smell or taste of food

with which it is combined

• Stable and dry preparation that can be

blended uniformly with the child’s food

• Zone IVB climate: maintains potency for 24

months at 30 ͦ C at 75% (RH). (minimum of 6 months data)

MNP Requirements

Specification

Vitamin Dose Form

Vitamin A 400 µg Acetate or palmitate (dry, CWS)

Vitamin D3 5 µg (200IU) Cholecalciferol (dry, CWS, beadlet)

Vitamin E 5 mg Dry Vitamin E (dl-alpha or d-alpha CWS)

Vitamin B1 0.5 mg Thiamine Mononitrate

Vitamin B2 0.5 mg Riboflavin

Vitamin B3 6 mg Niacinamide

Vitamin B6 0.5 mg Pyridoxine hydrochloride

Vitamin B12 0.9 µg Cyanocobalamin (1% or 0.1% SD)

Folic Acid 10 % 90 µg Folic Acid (10% anhydrous)

Vitamin C 30 mg mineral ascorbates (sodium or calcium are preferred)

Specification

Mineral Dose Form

Iron 10mg Ferrous fumarate (coated), ferrous bisglycinate, NaFeEDTA + fumerate (2.5mg + 7.5mg)

Zinc 4.1mg Zinc gluconate, sulphate preferred

Copper 0.56mg Copper gluconate is preferred, or Copper sulphate (coated) anhydrous

Selenium 17µg Sodium selenite anhydrous; Sodium Selenate or Selenomethionine

Iodine 90µg Potassium iodide or potassium iodate

Specification

• Maltodextrin (check GMO status) EP, USP

compliant, with low DE levels (9-11)

• Silica dioxide 0.5-2%

• Tricalcium phosphate

0.5-2%

Carriers and Excipients

Specification

• UNICEF labeling requirements (primary and

secondary) will now include a standard design

• Product name: Vitamin and Mineral Powder

• Must provide a barrier against humidity, light

and oxygen.

• Laminated foil, suggested composition :

PET 12 / Al 8 / PE 45

Sustainable packaging solutions for MNPs is an

area of interest for UNICEF

Packaging and Sachet requirements

Certificate of Analysis Requirements

• All actives within

limits (USP)

• Microbiological

criteria (USP)

• Moisture content

4.5% max

USP Monograph for MNPs

• UNICEF have been working with the Scientific

Liaison team for Dietary Supplements to create

a monograph for MNPs

• Several suppliers have co-operated in

providing the data the USP need to create this

monograph

• A draft for public review is expected to be

ready by June.

“Oil- and Water-soluble Vitamins and

Minerals for Oral suspension”

UNICEF Technical Assessment of MNPs

• Product documentation (Specs, 3 C of As, raw

materials)

• Stability studies and shelf life justification –

preference will be given to suppliers with

longer shelf life

• Certification – eg non GMO

• Sample evaluation (includes packaging)

• Label mock up compliance

• Questionnaires

MNPs – Requirements for Manufacturers

• Manufacturing Facilities and Standards

• UNICEF GMP inspections

• Major Observations from Inspections

• Significant complaints

Manufacturing Facilities and Standards

MNP can be manufactured at:

• Pharmaceutical Facilities -

WHO GMP for Pharmaceutical Products

• Food Supplement Facilities -

ISO 22000 Food Safety Management Systems

• Food Processing Facilities -

ISO 22000 Food Safety Management Systems

• Or any combinations thereof

Additional Standards

• Codex Alimentarius General Principles of Food Hygiene

CAC/RCP 1-1969 as amended

• ISO 9001: 2015 Quality Management Systems

• ISO 22003: 2007 Requirements for bodies providing audit

and certification of food safety management systems

• ISO 22004: 2014 Guidance on the application of ISO 22000

• Home Fortification Technical Advisory Group's manual on

micronutrient powder composition, July 2013

• WHO TRS No. 953, 2009 Annex 2 Stability testing of active

pharmaceutical ingredients and finished pharmaceutical

products

GMP inspections

Basic Principles:• All manufacturers are subject to GMP inspections prior

to approval for supply to UNICEF

• Inspection report sent to the manufacturer within 2

weeks of the inspection. Manufacturer’s response

expected within one month of report receipt.

• Follow up inspections to be carried out based on risk

and prior experience. Frequency is defined by level of

compliance (e.g. no. of observations, complaints, OOS

results)

Most Frequently Encountered Deficiencies (1)

QUALITY MANAGEMENT AND DOCUMENTATION

- HACCP plan not updated

- Poor handling of non conformities

- Weak investigations – poor corrective action implementation

- Prerequisite programmes (PRPs) not documented

- Inadequate control on issue, distribution and review of procedures

Most Frequently Encountered Deficiencies (2)

ORGANIZATION AND PERSONNEL

- Top management role and responsibilities notadequately defined

- No evaluation of training sessions – Missing

records

FACILITIES

- Storage conditions not monitored or not defined

- Inappropriate construction materials –poor maintenance

Most Frequently Encountered Deficiencies (3)

EQUIPMENT – UTILITIES

- Inappropriate design and qualification of HVAC system

- Unknown airflow patterns/ differential pressure cascade

- Incomplete verification/ qualification of production equipment

PRODUCTION

- Manufacturing process not validated

- Metal detectors not installed

- Incomplete batch record documentation

- Campaign working - Cleaning not defined

- Line clearance not documented

- No technical agreement for contract manufacturing/analysis

Most Frequently Encountered Deficiencies (4)

QUALITY CONTROL

- Incomplete analytical method validation

- Poor qualification and control of API suppliers

- Limited testing on raw materials and finished product

- Stability data not in support of current formulation and packaging

- Finished product specifications and release criteria not defined.

Major complaints

• Content of sachet has turned dark / brown

• Lumps in sachets

• Poor sealing of sachet

• OOS results following independent testing

• MNP not tasteless

Thank you