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International Food Additives Council Good Manufacturing Practice and Quality Assurance Guide for Food Additives and Gras Substances

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International Food Additives Council Good Manufacturing Practice and Quality Assurance Guide for Food Additives and Gras Substances INTERNATIONAL FOOD ADDITIVES COUNCIL GOOD MANUFACTURING PRACTICE AND QUALITY ASSURANCE GUIDE FOR FOOD ADDITIVES AND GRAS SUBSTANCES Table of Contents 1. INTRODUCTION ................................................................................................................................ 5 1.1 Purpose and Scope ........................................................................................................................ 6 1.2 Principles Adopted ........................................................................................................................ 7 1.2.1 The Guide and its Use ........................................................................................................... 7 1.2.2 Application ............................................................................................................................ 7 1.2.3 Quality System Standard ....................................................................................................... 7 1.2.4 Hazard Analysis and Risk-Based Preventive Controls ......................................................... 7 1.3 Document Structure ...................................................................................................................... 7 2. DEFINITIONS ...................................................................................................................................... 8 3. GENERAL GUIDANCE ...................................................................................................................... 8 4. QUALITY MANAGEMENT SYSTEM-FOOD ADDITIVE GRAS SUBSTANCE QUALITY SYSTEMS .................................................................................................................................................... 8 4.1 General Requirements ................................................................................................................... 8 4.2 Documentation Requirements ....................................................................................................... 9 4.2.1 General .................................................................................................................................. 9 4.2.2 Written Plan and Documentation of Preventive Controls ..................................................... 9 4.2.3 Quality Manual ..................................................................................................................... 9 4.2.4 Control of Documents ......................................................................................................... 10 4.2.5 Control of Records .............................................................................................................. 10 4.3 Change Control ........................................................................................................................... 11 4.4 Quality Management ................................................................................................................... 11 4.4.1 Management Commitment .................................................................................................. 11 4.4.2 Customer Focus................................................................................................................... 11 4.4.3 Quality Policy ..................................................................................................................... 11 4.4.4 Hazard Analysis and Risk-Based Preventive Controls ....................................................... 11 4.4.5 Planning .............................................................................................................................. 12 4.4.6 Responsibility and Authority .............................................................................................. 12 4.4.7 Management Review........................................................................................................... 13 5. RESOURCE MANAGEMENT .......................................................................................................... 14 5.1 Provision of Resources................................................................................................................ 14 5.2 Human Resources ....................................................................................................................... 14 5.2.1 General ................................................................................................................................ 14 5.2.2 Competence, Awareness and Training ................................................................................ 14 5.2.3 Personnel Hygiene .............................................................................................................. 15 5.3 Infrastructure ............................................................................................................................... 15 5.3.1 Buildings and Facilities ....................................................................................................... 15 2 5.3.2 Equipment ........................................................................................................................... 16 5.3.3 Utilities ................................................................................................................................ 17 5.3.4 Water ................................................................................................................................... 17 5.4 Work Environment ...................................................................................................................... 17 5.4.1 Air Handling ....................................................................................................................... 17 5.4.2 Controlled Environment ...................................................................................................... 17 5.4.3 Cleaning and Sanitary Conditions ....................................................................................... 18 5.4.4 Pest Control ......................................................................................................................... 18 5.4.5 Lighting ............................................................................................................................... 18 5.4.6 Sewage and Refuse ............................................................................................................. 18 5.4.7 Washing and Toilet Facilities ............................................................................................. 18 6. PRODUCT REALIZATION .............................................................................................................. 18 6.1 Planning of Product Realization ................................................................................................. 18 6.2 Customer-Related Processes ....................................................................................................... 19 6.2.1 Determination of Requirements Related to the Product...................................................... 19 6.2.2 Review of Requirements Related to the Product ................................................................ 19 6.2.3 Customer Communication .................................................................................................. 19 6.3 Design and Development ............................................................................................................ 19 6.4 Purchasing ................................................................................................................................... 20 6.4.1 Purchasing Process .............................................................................................................. 20 6.4.2 Purchasing Information ....................................................................................................... 20 6.4.3 Supplier Qualification and Periodic Verification ................................................................ 20 6.4.4 Verification of Purchased Product ...................................................................................... 21 6.5 Production and Service Provision ............................................................................................... 21 6.5.1 Control of Production and Service Provision ...................................................................... 21 6.5.2 Verification of Processes for Production and Service Provision ........................................ 24 6.5.3 Identification and Traceability ............................................................................................ 24 6.5.4 Customer Property .............................................................................................................. 25 6.5.5 Preservation of Product ....................................................................................................... 25 6.6 Control of Measuring and Monitoring Devices .......................................................................... 26 7. MEASUREMENT, ANALYSIS AND IMPROVEMENT ................................................................. 26 7.1 General ........................................................................................................................................ 26 7.2 Monitoring and Measurement ..................................................................................................... 27 7.2.1 Customer Satisfaction ........................................................................................................
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