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Home fortification, using Multiple Micronutrient Powders Products, Procurement and Supply Jan Komrska & Alison Fleet UNICEF Supply Division Medicines and Nutrition Center, Nutrition Unit Slide 2 Outline Key product characteristics How MNP products could be purchased/ordered? Product Price Manufacturing Process Slide 3 Objective of the Supply To deliver right quantities of right product, to the right locations and at the right time. To minimize costs and to satisfy quality requirements. Slide 4 Supply Process Plan Procure Produce Deliver Expression of need for a product Product arrives to the port of entry Slide 5 Definition of requirements What? How many? Where? When? How much? Plan Specification Quantity Delivery address Delivery date Available budget Slide 6 Product Plan Vitamin and Mineral Powder (MNP) Slide 7 Specifications (HF TAG) Name of the product VITAMIN and MINERAL POWDER Composition 15 components Label language English x local language Instructions for use Text x Pictograms Plan Slide 8 Standard Product (1) Plan Slide 9 Standard Product (2) Plan Slide 10 Standard Product (3) Plan Available through UNICEF Supply Division Suitable for pilot projects or small orders Slide 11 Customised Products Plan Yemen Haiti Nepal Kyrgyzstan Rwanda Slide 12 Product characteristics Plan Product shelf life 2 years Under storage conditions indicated by the manufacturer Slide 13 Quantification of needs Good forecast and higher volumes result in: Cost saving (obtaining better price from the supplier) Better lead time Less stock in warehouse Uninterrupted supply Plan Slide 14 Timelines Plan Standard product Customised product Confirmation of Layouts3 4 weeks Warehouse Processing4 weeks Production8 12 weeks Shipment by Sea4 6 weeks Clearance at the port2 weeks TOTAL10 12 weeks17 24 weeks Slide 15 Lessons Learnt Product specification - refer to HF TAG Programmatic Note Customisation of the product layouts possible but allow enough time Product shelf life is short plan for continuous orders to avoid long storage time Storage conditions need to be adhered to keep the product fresh Forecasting product quantities is very important Plan Slide 16 Principles of public procurement: Fairness Transparency Equal treatment Registration of the product: Law on medicinal product for human use Import/VAT regulations Procure Regulatory environment (1) Slide 17 Why MNP should not be registered as medicine? Product does not claim to treat a specific disease Product is not usually manufactured by pharmaceutical companies Premix components comply with the Food Chemical Code (FCC) not Pharmacopoeias Product is not distributed exclusively through pharmacies MNP should be registered as food supplement however country specific constrains may require other registration avenues Procure Regulatory environment (2) Slide 18 Supplies of MNP Procure 2011: 4 million monthly doses purchased 2012: 9 million monthly doses purchased Slide 19 MNP Prices Procure 0.025 USD/sachet ~ 0.75 USD/PAC-30 Additional costs: -Shipping cost -Clearance -Customs duties Programming costs Slide 20 HF Products Prices Procure Slide 21 How could home-fortification products be ordered/ procured? Through Agencies (UNICEF country programme / WFP / NGOs) Through Procurement Agents (UNICEF Procurement Services or GAIN Premix Facility) Direct procurement by the governments from manufactures or appointed traders Procure Slide 22 Procurement through UN Agencies UNICEF country programme / WFP / NGOs Advantage: Funding is secured outside government (initial phases) Good product quality and good price Disadvantage: Product is imported, cleared under Agencies' name Capacity of the government is not built Capacity of the local industry is not built Suitable for initial stages of programs/pilots and in emergency response phase Procure Slide 23 Through Procurement Agents Through UNICEF Procurement services (PS) or GAIN Premix Facility (GPF) Advantage: Government is securing funds (through own resources or donors) Good product quality and good price GAIN provides credit arrangement Product is imported, cleared under Governments' name Disadvantage: Advance payment is required by UNICEF Capacity of the government is not built Capacity of the local industry is not built Often conditioned by Donors Suitable for nationwide distribution Procure Slide 24 Government direct procurement From the manufacturer or appointed traders Advantage : Government is securing funds Ownership Capacity building for local industry Disadvantage : Prone to irregularities during the procurement process Technical capacity to evaluate product quality might be a challenge Product quality may become less important in selection process Challenge when no local suppliers/agents available Suitable for nationwide distribution Procure Slide 25 Lessons Learnt International purchase: Results in better price compared to local purchase Quality of product is easier to assure Conducting open international bidding might be difficult to implement for national authorities Challenges in technical evaluation: Limited data on product provided by supplier Stability study to confirm product shelf life is not available Procure Slide 26 Manufacturing process (1) Requirements for food manufacturers: 1.Licence for food manufacturing 2.Hazard Analysis and Critical Control Points (HACCP) 3.Recommended International Code of Practice - General Principles of Food Hygiene of Codex Alimentarius 4.ISO 22000:2005 (Food Safety Management System) Produce Slide 27 Requirements for the product: Safety, Efficacy, Quality Stability Data Certificates of Analysis (CoA) Premix Finished product Raw materials CoA Produce Manufacturing process (2) Slide 28 Premix Finished product Raw materials Produce Manufacturing process (3) BlendingPackaging Slide 29 Local production of MNP requires Investment in 1 gram sachet filling machine Compliance to strict hygiene and quality rules Import of pre-mix and foil It is not cheaper compared to international procurement Produce Manufacturing process (4) Slide 30 Packaging of sachets Produce Slide 31 Finished product Produce Slide 32 UNICEF Approved Suppliers DSM France/Bulgaria DSM South Africa DSM/Fortitech Malaysia Renata, Bangladesh Piramal Healthcare, India Potential suppliers: Stern Vitamins, Germany Glanbia, Germany Produce Consult HF TAG website Slide 33 Lessons learnt Limiting points in manufacturing process Capacity of the blender Capacity of the packaging machine Customized foil production time Manufacturers understanding of quality requirements varies Finished product analysis are not carried out systematically Produce Slide 34 Product Receipt Deliver About 100,000 packs in one 20 container Slide 35 Product Storage Deliver Product must be stored as per product label (dry, clean storage below 25 C) Good distribution practice (batch management and tractability Product expiry date Slide 36 Complaints Deliver Color Odor Layouts Not possible to open sachets Slide 37 Lessons learnt Respect suppliers instruction on how to store HF products ( even though these products are not classified as pharmaceuticals ) Allow sufficient time for stock replenishment/reordering to avoid stock outs Provide feedback to purchaser/person who drafted specification to implement improvements Deliver Slide 38 Thank you ! Plan Procure Produce Deliver