Technical requirements Nutrition products Anna Kistauri Medicines and Nutrition Centre UNICEF Supply Division Nutrition Supplier Meeting 11 September 2013 Copenhagen
Nutrition Unit Anthropometrics Supplementary food Food fortification Therapeutic food Salt iodization
Supply catalogue http://www.unicef.org/supply/
Technical requirements Quality Safety Efficacy Manufacturing environment
Manufacturing standard Codex Alimentarius ISO 22000:2005 - Food Safety Management Systems ISO 9001:2000, ISO 9002 GMP, GHP HACCP
Manufacturing site Production Sterilization Packaging Quality control Manufacturing license UNICEF approval Contract manufacturer
Ingredients CoA Descriptions of tests and limits Changes to be notified
GMP Inspection Manufacturing site Production process Quality control Quality assurance Packing Documentation In conjunction with National Regulatory Authority
Shelf life Less than 4 months old at time of delivery
Packaging As specified in the bid document Must be of sturdy export quality, providing adequate protection of goods for carriage by air, sea and/or road as well as during the storage
Labeling Codex standards on nutrition labeling Nutrition claim and listing of ingredients - Codex STN 146-1985: General Standard for labeling of and Claims for prepackaged Foods for Special Dietary Uses - Codex STAN 1-1985: General Standard for the Labeling of Prepackaged foods
Labeling Generic name Name, address of the manufacturer Net weight Manufacturing date Best before date Storage conditions Instructions for use, any warning, etc. notes Batch number
Quality control Manufacturer: Finished product specifications Elaborating analytical plan Testing of each ingredient CoA for each batch (tracers, microbiological tests)
Complete batch analysis Varies depending on production capacity and order frequency New suppliers 3 months, then 6 months <1000 MT per year once a year 1000-2000 MT 6 months 2000-12000 MT 3 months >12 000 MT monthly ISO 17025 certified laboratories (preferably)
Product Safety Microbiological and Chemical safety CAC/GL 21, 1997, the Principles for the Establishment and Application of Microbiological Criteria for Foods (revision scheduled for 2013). CAC/GL 63-2007: Principles and guidelines for the Conduct of Microbiological Risk management (MRM) Environmental monitoring program
Chemical Safety (Tested once a year or as required) CAC/RCP 49-2001: Code of Practice for Source Directed Measures to Reduce Contamination of food with Chemicals Pesticides and Heavy Metals CODEX STAN 228-221: General Methods of Analysis for Contaminants CODEX STAN 193-1995: Codex Standard for Contaminants and Toxins in Food an Feed CODEX STAN 229-1993, REV.1-2003: Analysis of Pesticide Residues: Recommended Methods
Chemical Safety Radioactivity Radioactivity free ingredients (if applicable) Nuclear radiation level values valid in the area of consumption Maximum 370 bq/kg Melamine Maximum 1 mg/kg COMMISSION REGULATION (EU) No 594/2012 of 5 July 2012 amending Regulation (EC) 1881/2006 as regards the maximum levels of the contaminants ochratoxin A, non dioxin-like PCBs and melamine in foodstuff.
Technical evaluation Conducted as part of a bidding exercise Based on comparison of offered product with Product specification in a bid document Evaluation criteria are clearly listed in a bid document Requested documentation/sample must be submitted
Documents and samples Questionnaires Finished product specification MSDT (when applicable) CoA Manufacturing license Stability studies Raw material specifications Packaging material specifications Copy of the label, leaflet, instructions of use, etc. Certificates as required in different countries Sample if required
Stability Studies Long-term and accelerated stability studies should be provided Accelerated testing at 40±2 C/75±5%RH/6 months and real time testing at 30±2 C/65±5%RH http://www.who.int/medicines/publications/pharmprep/pdf_tr s953.pdf
Thank you!