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[资源] Food CGMP Modernization — A Focus on Food Safety

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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