Technical requirements Nutrition products

Transcription

1 Technical requirements Nutrition products Anna Kistauri Medicines and Nutrition Centre UNICEF Supply Division Nutrition Supplier Meeting 11 September 2013 Copenhagen

2 Nutrition Unit Anthropometrics Supplementary food Food fortification Therapeutic food Salt iodization

3 Supply catalogue

4 Technical requirements Quality Safety Efficacy Manufacturing environment

5 Manufacturing standard Codex Alimentarius ISO 22000: Food Safety Management Systems ISO 9001:2000, ISO 9002 GMP, GHP HACCP

6 Manufacturing site Production Sterilization Packaging Quality control Manufacturing license UNICEF approval Contract manufacturer

7 Ingredients CoA Descriptions of tests and limits Changes to be notified

8 GMP Inspection Manufacturing site Production process Quality control Quality assurance Packing Documentation In conjunction with National Regulatory Authority

9 Shelf life Less than 4 months old at time of delivery

10 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

11 Labeling Codex standards on nutrition labeling Nutrition claim and listing of ingredients - Codex STN : General Standard for labeling of and Claims for prepackaged Foods for Special Dietary Uses - Codex STAN : General Standard for the Labeling of Prepackaged foods

12 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

13 Quality control Manufacturer: Finished product specifications Elaborating analytical plan Testing of each ingredient CoA for each batch (tracers, microbiological tests)

14 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 MT 6 months MT 3 months > MT monthly ISO certified laboratories (preferably)

15 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 : Principles and guidelines for the Conduct of Microbiological Risk management (MRM) Environmental monitoring program

16 Chemical Safety (Tested once a year or as required) CAC/RCP : Code of Practice for Source Directed Measures to Reduce Contamination of food with Chemicals Pesticides and Heavy Metals CODEX STAN : General Methods of Analysis for Contaminants CODEX STAN : Codex Standard for Contaminants and Toxins in Food an Feed CODEX STAN , REV : Analysis of Pesticide Residues: Recommended Methods

17 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.

18 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

19 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

20 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 s953.pdf

21 Thank you!