cGMP regulation overhaul presents challenges, opportunities

David Bellm

January 30, 2014

2 Min Read
cGMP regulation overhaul presents challenges, opportunities

First introduced in 1969 and revised in 1986, FDA cGMP regulations are now in the midst of a new modernization initiative. While final regulations have not been released, there are some significant modernization opportunities likely to affect food manufacturers in the future.  

Some of these are highlighted in a 2005 FDA “white paper” — including requirements for training for supervisors and workers, written allergen control plans where food allergens are present, written environmental pathogen control plans where needed, written sanitation procedures for all food contact equipment and food contact surfaces, and time-temperature dynamics for refrigerated and hot foods storage.

GMA’s Manufacturing Excellence Conference at PACK EXPO International 2010 will bring together experts including Craig Henry, AERS Deloitte & Touché LLP, and Faye J. Feldstein, formerly of the FDA, to share insights on these and other modernization opportunities and the potential impact this initiative may have on food manufacturing.


Craig Henry, Ph.D., Director, AERS Deloitte & Touche LLP
Craig is one of the leaders of Deloitte’s globally effort to food and product safety that enhance supply chain integrity and visibility as well as integrates risk and compliance approaches. Prior to joining Deloitte Dr. Henry served as Senior Vice President in the Scientific and Regulatory Affairs department of the Grocery Manufacturers Association and as the Executive Director of the GMA Science and Education Foundation.  Dr. Henry currently serves as a co-chairperson for the federal Food and Agricultural Sector Coordinating Council representing the private sector of the food industry.
Faye J. Feldstein, MS  former Director of Food Defense and Emergency Response, FDA
Faye has a solid foundation in food safety, microbiology and food defense, gained during her career in industry, and state and federal regulatory agencies.  Most recently, her career has been highlighted by a 10 year tenure at the Food and Drug Administration, Center for Food Safety and Applied Nutrition, where she was the Director of the Agency’s Office of Food Defense and Emergency Response.

"It is critically important to have the industry, manufacturers and suppliers alike, understand the significance and scope of FDA's pending modernization of the cGMPs.  Ensuring food safety and public confidence is the responsibility of every stakeholder."  — Craig Henry, Ph.D., Deloitte & Touché; and Faye Feldstein, MS, former Director of Food Defense and Emergency Response, FDA



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