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!