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Drs. Manfred Septinus and Hector Cori of DSM Nutritional "Code Of Practice For Food Premix Operations (Nutrition Unit, Family and Community Health Area)"

PREFACE

Food fortification with micronutrients is one of the most important strategies for increasing the intake of vitamins and minerals of public health significance and improving the nutritional status of people on a continuous and self-sustaining basis. In the Americas, wheat and/or corn flour are widely consumed and are excellent vehicles for fortification with micronutrients. Nearly all the countries in the Region are already fortifying wheat and/or corn flour with iron, folic acid, and other B-complex vitamins. Other widely-consumed staple foods, such as sugar, milk and vegetable oil, and targeted foods consumed by specific population groups, such as infant formulas and cereals and commercial complementary foods, are being fortified with micronutrients.

Experience in food fortification gathered over many years have helped to identify specific actions to strengthen food fortification programs and assure that designated foods are adequately fortified and delivered to the population. Factors for limited success of food fortification programs include the lack of or weak regulations, suboptimal types and concentrations of fortificants, poor manufacturing practices and standards for fortified foods, lack of or weak quality control/quality assurance systems, and lack of demand generation through consumer awareness and participation. Developing methods and implementing actions to address these issues are key to assuring effective and sustainable food fortification programs. In the Americas, PAHO/WHO and various partner organizations are working to address these issues, particularly in developing guidelines for taking sound actions. In January 2001, PAHO, the Human Nutrition Institute of the International Life Sciences Institute (ILSI), and the U.S. Agency for International Development (USAID) through the International Nutritional Anemia Consultative Group (INACG) organized a technical consultation to develop practical guidelines on the types and levels of iron compounds recommended for food fortification. These guidelines based on currently available scientific evidence were widely disseminated for use in the Latin American and the Caribbean countries. In January 2003, PAHO with the March of Dimes (MOD) and the Centers for Disease Control and Prevention (CDC) organized a second technical consultation to establish guidelines for recommended levels of fortification with folic acid and vitamin B12. Following these two technical consultations, PAHO, CDC, MOD, UNICEF, and the Institute of Nutrition and Food Technology (INTA) of the University of Chile held a regional meeting with participants from 20 countries in the Americas. The purpose of this meeting was to translate current scientific knowledge into practice, by transferring the information for optimizing flour fortification into the hands of policy-makers and program implementers. The meeting provided a forum for participants representing the Ministries of Health, the regulatory or food control agencies, and flour millers in each country to exchange ideas, experiences, concerns, and needs. The discussions resulted in the recommendations by the countries on specific activities to improve food fortification programs.

One of the recommendations was in reference to the need for guidelines and mechanisms for assuring the quality of food premixes. With the growing number of commercial premix suppliers in the Region, both the public health authorities and food producers recognize the need to assure premix quality not only in terms of adequate types and levels of nutrients added but also in relation to hygiene, food safety, and good manufacturing practices, thereby assuring that the premix meets the minimum requirements for human consumption.

This Code of Practice for Food Premix Operations is the first response to a need raised by the implementers of food fortification programs. The first step to assuring premix quality will be the adoption of this Code by premix operators for their internal audit. The next steps will include developing a system of external auditing and certification of premix quality by regulatory agencies at the regional or sub-regional level. PAHO/WHO is pleased to produce the Code of Practice for Food Premix Operations and contribute to building effective food fortification programs to eliminate micronutrient deficiencies and improve the health and nutrition of populations.

Contents:

Code Of Practice For Food Premix Operations

Cover

Copyright

Table Of Contents

Acknowledgements

PREFACE

INTRODUCTION

SCOPE

TERMS AND DEFINITIONS

QUALITY MANAGEMENT SYSTEM (QMS)

3.1 General Requirements

3.2 Quality Policy

3.3 Quality Manual

3.4 Organizational Structure, Responsibility and Management Authority

3.5 Documentation Control

3.6 Procedures

3.7 Product Control

3.7.1 Specifications

3.7.2 Incoming materials

3.7.3 Product manufacturing, packaging and labeling

3.7.4 Segregation

3.7.5 Stock rotation

3.7.6 Product release

3.7.7 Cross-contamination

3.7.8 Carry-over

3.8 Process Control

3.8.1 Quality control

3.8.2 Calibration

3.8.3 Reference samples

3.8.4 Temperature and time control

3.8.5 Equipment validation

3.8.6 Supervision

3.8.7 Statistical techniques

3.9 Internal Audit

3.10 Control of Non-Conforming Products

3.11 Traceability

3.12 Record Keeping

3.13 Product Recall

3.14 Complaint Handling System

3.15 Supplier Audit Monitoring

3.16 Upper Management Responsibilities

3.16.1 Review of contracts

3.16.2 Customer communication

3.16.3 Provision of resources

3.16.4 Management review

GMP-PREREQUISITE PROGRAMS

4.1 Establishment: Design and Facilities

4.1.1 Location

4.1.2 Perimeter

4.1.3 Layout/product flow

4.1.4 Infrastructure/facilities

4.1.5 Equipment

4.1.6 Staff facilities and toilets

4.1.7 Waste/waste disposal

4.2 Personnel

4.2.1 Personal hygiene

4.2.2 Protective clothing

4.2.3 Training

4.3 Pest Control

4.4 Maintenance

4.5 Hygiene/Cleaning

4.6 Transport and Storage

4.6.1 Vehicles/transport

4.6.2 Storage

FOOD SAFETY

5.1 Foreign Material Control

5.2 HACCP Program

5.3 Design and Development

5.3.1 Development of new products and processes

5.3.2 Change control

AUDIT GUIDELINES

APPENDIX 1. AUDIT SCORE

AUDIT SCORE SHEET

1. QUALITY MANAGEMENT SYSTEM SCORE COMMENTS

2. GMP-PREREQUISITE PROGRAMS SCORE COMMENTS

3. FOOD SAFETY SCORE COMMENTS

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