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Good Manufacturing Practice (GMP) regulations help the U.S. Food and Drug Administration (FDA) protect consumers by confirming the safety and quality of consumable food products. The FDA carefully monitors manufacturers, packagers, labelers and holders of food to ensure it is suitable for human consumption. The mandated and required GMP regulations cover all aspects of production, including having the necessary facilities to receive, inspect, transport, prepare, package and store food products.


Contact us today to learn more about our GMP consulting services and how we can assist your organization with GMP compliance.

Benefits of 21 CFR Part 110

• Ensure food products are safe for human consumption

• Ensure the safety and suitability of food-packaging materials 

• Comply with federal and statutory laws and regulations

• Prevent sanitation failures or contamination

• Reduce consumer risks

• Meet requirements for GMP compliance or certification



How We Can Help

The ISO 9001 Group understands 21 CFR Part 110 regulations and how to comply with them. Our consulting service provides assistance with FDA registration, pre-audit, FDA inspections and responding to FDA warnings letters. Our GMP consultants will work with you to implement the applicable FDA regulations to ensure effective, efficient and compliant good manufacturing practices.


Federal Regulations:

21 CFR Part 110. Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food


Our proven, hands-on GMP consulting service ensures that your food manufacturing practices comply with FDA regulations and pass FDA inspections.



21 CFR Part 110 Overview

Subpart A – General provisions

Subpart B – Buildings and Facilities

• Plant and grounds

• Sanitary operations

• Sanitary facilities and controls.

Subpart C – Equipment

• Equipment and utensils

Subpart D [Reserved]

Subpart E – Production and Process Controls

• Processes and controls

• Warehousing and distribution

Subpart F [Reserved]

Subpart G – Defect Action Levels

• Natural or unavoidable defects in food for human use that present no health hazard


Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.

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