Micronutrient Powders (MNPs)

Transcription

1 27 April 2017 Pre-bid Conference Micronutrient Powders (MNPs)

2 Pre-bid Conference: Micronutrient Powders (MNPs) AGENDA 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

3 Micronutrient Powders (MNPs) What are they? 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.

4 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

5 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

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7 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

8 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

9 Million sachets Procurement history (1) Started to purchase in 2007 Exponential increase over the last 10 years (1,188 M sachets in 2016) 1,200 Product Demand 1, component - local layout 15 component - local layout 15 component - standard layout

10 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 Number of countries ordering MNPs Ordering countries

11 Millions Procurement history (3) LTAs in place with 5 suppliers Current LTAs valid since July Number of packs procured DAP CPH warehouse FCA point of departure

12 Procurement history (4) Customized layout for better compliance Gradual shift with now 2/3 customized 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Micronutrient Powder Demand by Layouts Type 0% Standard layout Customised layout

13 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.

14 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 (oncontinent production, waste generation,..) Establish time-bound 6-7 LTAs for July 2017 July 2019 (2020) with multiple manufacturers

15 Forecast 60 million packs for 2 years (1,800 million sachets) $30-35 million for 2 years

16 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

17 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

18 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

19 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)

20 Bids Submission Bids shall be submitted in response to the RFP by to (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)

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22 UNICEF Product Requirements MNP 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)

23 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 B 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)

24 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

25 Specification Carriers and Excipients Maltodextrin (check GMO status) EP, USP compliant, with low DE levels (9-11) Silica dioxide 0.5-2% Tricalcium phosphate 0.5-2%

26 Specification Packaging and Sachet requirements 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

27 Certificate of Analysis Requirements All actives within limits (USP) Microbiological criteria (USP) Moisture content 4.5% max

28 USP Monograph for MNPs Oil- and Water-soluble Vitamins and Minerals for Oral suspension 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.

29 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

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31 MNPs Requirements for Manufacturers Manufacturing Facilities and Standards UNICEF GMP inspections Major Observations from Inspections Significant complaints

32 Manufacturing Facilities and Standards MNP can be manufactured at: Pharmaceutical Facilities - WHO GMP for Pharmaceutical Products Food Supplement Facilities - ISO Food Safety Management Systems Food Processing Facilities - ISO Food Safety Management Systems Or any combinations thereof

33 Additional Standards Codex Alimentarius General Principles of Food Hygiene CAC/RCP 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 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

34 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)

35 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

36 Most Frequently Encountered Deficiencies (2) ORGANIZATION AND PERSONNEL - Top management role and responsibilities not adequately defined - No evaluation of training sessions Missing records FACILITIES - Storage conditions not monitored or not defined - Inappropriate construction materials poor maintenance

37 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

38 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.

39 Major complaints Content of sachet has turned dark / brown Lumps in sachets Poor sealing of sachet OOS results following independent testing MNP not tasteless

40 Thank you