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 ........................................................................................................