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Food CGMP Modernization — A Focus on Food Safety
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November 2, 2005 Food CGMP Modernization Working Group Center for Food Safety and Applied Nutrition U. S. Food and Drug Administration Comments regarding this document may be submitted at any time. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the Docket Number 2004N-0230. Table of Contents Executive Summary Introduction The Need for Food CGMP Modernization A Risk-Based Approach to CGMP Modernization FDA Sponsored CGMP Research The Public Response to FDA's Call for Information on CGMP Modernization Questions Posed by the Agency General Comments Definitions Lubricants Lot Size Raw Agricultural Commodities Finished Product Testing Allergen Controls Manufacturing Operations Warehousing and Distribution Written Sanitation Practices Environmental Monitoring Maintenance of Records and Access to Records HACCP and CGMP Regulations "Shall" vs. "Should" Training Temperature Requirements Validation of Preventive Controls Employee Health Cleanliness Plant and Grounds Sanitary Operations Filtration Imported foods Agency Access to Records Opportunities for Modernization of 21 CFR Part 110 Training Requirements Food Allergen Controls Listeria monocytogenes Control Written Sanitation Procedures Application of CGMP Regulations to Certain Agricultural Operations Records Maintenance and Access Temperature Controls Executive Summary |
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