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Current Good Manufacturing Practices (CGMPs) > Good

Manufacturing Practices (GMPs) for the 21st Century

August 9,2004

Table of Contents

Executive Summary

Section One Current Food Good Manufacturing Practices

1. 1.1 The Development of Food GMPs

2. 1.2 Key Provisions of Food GMPs

1. 1.2.1 General Provisions (Subpart A)

2. 1.2.2 Buildings and Facilities (Subpart B)

3. 1.2.3 Equipment (Subpart C)

4. 1.2.4 Production and Process Controls (Subpart E)

5. 1.2.5 Defect Action Levels (Subpart G)

6. References

Section Two Literature Review of Common Food Safety Problems and Applicable Controls

1. 2.1 Microbiological Safety

2. 2.2 Chemical Safety

3. 2.3 Physical Safety

4. 2.4 Other Considerations

5. References

Section Three Previous Surveys of Manufacturing Practices in the Food Industry

1. 3.1 Meat and Poultry Listeria Reassessment Survey

2. 3.2 Listeria Reassessment-Evaluation Report

3. 3.3 Food Processing Magazine's Annual Manufacturing Trends Survey

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4. 3.4 Food Engineering Magazine's Annual Best Manufacturing Practices Survey

5. 3.5 A Survey of Control System Validation Practices in the Food Industry

6. 3.6 Automation Practices in the Food Industry

7. 3.7 Survey on the Use of Computer-Integrated Manufacturing in Food Processing Companies

8. 3.8 FDA HACCP Survey

9. 3.9 Survey of Maryland Cider Producer Practices

10. References

Section Four Common Food Safety Problems in the U.S. Food Processing Industry: A Delphi Study

1. 4.1 Methodology

2. 4.2 Results

1. 4.2.1 Round 1 Results

2. 4.2.2 Round 2 Results

3. 4.2.3 Round 3 Results

4. 4.2.4 Post-Study Discussions with Select Experts

1. Additional Resources Recommended

2. Current Government Programs of Potential Interest

3. References

Appendix A Annotated Bibliography on Food Safety Problems and Recommended Preventive Controls

Appendix B Definitions of Food Safety Problems

Appendix C Examples of Preventive Controls and/or Corrective Actions for the Top Ten Food Safety Problems

Appendix D Exploratory Factor Analysis

Appendix E Comparison of Food GMPs to Quality Systems and Other GMPs

Executive Summary

Since the last revision of food Good Manufacturing Practices (GMPs) almost 20 years ago, the food manufacturing
industry has seen many changes, including newly recognized pathogens, more sophisticated technologies, and

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increased automation. While GMPs can control for many food safety problems, it is not clear that current GMPs
adequately address these new developments. The food safety literature reviewed for this study shows that there
continue to be food safety problems. The Food and Drug Administration (FDA) is currently evaluating its food GMPs
regulations to ensure that they take today's technologies and food safety hazards into account.

Under contract to FDA, Eastern Research Group, Inc. (ERG) undertook this study comprising an extensive literature
review and an expert elicitation of current food safety problems and the range of preventive controls needed to address
them. The expert elicitation identified the most significant food safety problems, foods at high risk for these problems,
and other major areas of concern. Based on the number of votes by experts who participated in the elicitation,
"deficient employee training," "contamination of raw materials," "poor plant and equipment sanitation," and "poor
plant design and construction" were ranked as the top four food safety problems faced by food manufacturers today.
Results from the study also indicated that refrigerated and dairy foods have the highest general risk of food safety
problems compared to other food categories. Baked and refrigerated foods pose the highest risk in terms of allergen
hazards. The expert elicitation also showed that the needs of small and medium-sized food processors likely vary from
larger processors, with smaller facilities generating higher risk scores than large facilities across all food safety
problems and sectors considered.

The food safety experts who participated in the study recommended a range of preventive controls that could address
most of the food safety problems faced by the food processing industry today. They did not, however, differentiate these
preventive control recommendations by facility size despite the higher risk rankings of smaller facilities. The most
frequently mentioned preventive controls with broad applicability across sectors and food safety problems included:

Training -- Ongoing and targeted training on issues ranging from allergen control, cleaning and sanitation
procedures, incoming ingredient receipt protocol, and monitoring for employees, management, as well as

Audits -- Periodic audits and inspections of facility and raw material suppliers either in-house or by third-party

Documentation -- Documentation of training activities, raw material handling policies and activities, cleaning and
sanitation, receiving records, and use of sign-off logs, and

Validation/Evaluation -- Evaluation of training effectiveness and establishment of accountability; validation of

cleaning through testing (i.e., swabs, organoleptic evaluations, and bioluminescence tests)

Post-study follow-up discussions with four of the experts also generated additional recommendations. While most
experts agreed that food GMPs could be improved, opinions on how this should be done varied widely. Some experts
indicated that GMPs were lacking in some areas, whereas others noted that the food GMPs should remain as written
and that other approaches should be taken to encourage greater compliance. Recommendations made included:

Revision of food GMPs in key areas, such as training,

Addition of new requirements, including components of HACCP, allergen control, and record keeping,

Issuance of a guidance document that would clarify GMPs and its expectations, and

Institution of positive incentive programs, such as reduced inspections for select facilities that meet certain

Finally, ERG's literature review and comparative analysis of other GMPs (i.e., for pharmaceutical/biologic products
and medical devices) and quality system programs revealed that the majority of preventive control recommendations
echo the principles of these other GMPs regulations and quality systems. All of the programs reviewed, including

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International Organization for Standardization (ISO) 9001: 2000, American Society for Quality (ASQ) Q9004-3-1993
(Quality Management and Quality System Elements -- Guidelines for Processed Materials), pharmaceutical GMPs,
and medical device GMPs, have similar key provisions on training, audits, documentation, and evaluation/validation.
A thorough comparison of the elements of food GMPs to these systems (see Appendix E) might aid FDA in its food
GMPs modernization effort.

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