This standard specifies basic requirements and management rules for site, facilities and personnel in procedures such as purchasing, processing, packaging, storage and transportation of raw materials in the production process of formula foods for special medical use.
This standard is applicable to production enterprises of formula foods for special medical use (including infant formula foods for special medical use).
1 Scope 2 Terms and Definitions 3 Site Selection and Plant Environment 4 Plant Building and Workshop 5 Equipment 6 Hygiene Management 7 Requirements for Raw Material and Packaging Material 8 Food Safety Control During Production 9 Verification 10 Inspection 11 Product Storage and Transportation 12 Product Tracing and Recall 13 Training 14 Management System and Personnel 15 Record and Document Management 16 Effectiveness Monitoring and Evaluation of Food Safety Control Measures Appendix A Computer System Application Guide for Production Enterprises of Formula Food for Special Medical Purpose Appendix B Environmental Monitoring Guide for Salmonella, Enterobacter Sakazakii and Other Enterobacteriaece in Cleaning Work Area of Powder Formula Foods for Special Medical Use Appendix C Commercial Sterilization Operation Guide for Liquid Formula Foods for Special Medical Use
