Professional Documents
Culture Documents
FSMA - GMP Checklist
FSMA - GMP Checklist
To comply with The Food Safety Modernization Act (FSMA) provisions, all registered facilities
must comply with the Good Manufacturing Practices (GMP) for Human Food standards. This
checklist will help you organize your materials and assess your operation’s current food safety
preparedness for GMP rules. The Checklist is NOT itself a plan; only an assessment tool to
assist in development of food safety protocols specific for your operation. We recommend you
approach meeting GMP rules from the viewpoint of filling missing gaps and creating new
efficiencies within operations rather than regulatory compliance. This Checklist is for Current
Good Manufacturing Practices for Human Food found in 21 CFR Part 117.
Current Good Manufacturing Practices consists of 9 sections:
1) Personnel §117.10
2) Plant and grounds §117.20
3) Sanitary operations §1117.35
4) Sanitary facilities and controls §117.37
5) Equipment and utensils §117.40
6) Processes and controls §117.80
7) Warehousing and distribution §117.93
8) Holding and distribution of human food by-products for use as animal food §117.95
9) Defect action levels §117.110
We recommend reviewing the operation with the Checklist in hand and document current status.
The next step would be to approach one section at a time and collecting/listing documentation in
each part as you go. This method is straightforward and will be easier than trying to do the
whole checklist in one session or skipping around among parts. This Checklist is available as a
Word document that can be downloaded and saved. If the answer to a question is currently NO,
then this item should be seen as an area for improvement. Ensuring safety of food is a continuous
process. This Checklist is intended for operator use only with the goal of organizing and
documenting what standards are currently met and which need improvement. The Checklist is
not part of a regulatory compliance program.
Contacts:
Dr. Angela Shaw
Iowa State University
Assistant Professor/Extension and Outreach
Food Safety/Microbiology
2577 Food Science, Ames, IA
515-294-0868
angelaml@iastate.edu
These materials are provided for educational and informational purposes only. The materials
are not a substitute for professional advice, whether legal or otherwise. These materials are
intended, but not promised or guaranteed to be, current, complete, or accurate. Users are
responsible for any consequences resulting from their use of the materials. Copying and
redistribution without change is allowed with attribution.
V. 1.2 05/03/2016 Copyright © 2012-2016, Iowa State University of Science and Technology. All Rights
Reserved.