Modernized cGMP: The Nuts And Bolts Of A Preventive Controls Food Safety Plan

By Omar Oyarzabal, Ph.D., University of Vermont Extension

Many of the HACCP plans I see are not well-integrated with prerequisite programs at the facility. Because of this, the food safety system is not robust enough. In this first article of a two-part series, I will make the point that focusing on prerequisite programs, starting with Current Good Manufacturing Practice (cGMP) is the best starting point for any conversion of a HACCP plan into a Preventive Controls Food Safety Plan.

When converting a HACCP plan into a Preventive Control Food Safety Plan, a general assumption is that critical control points (CCPs) are converted into process preventive controls. That would be correct and that part of the conversion is relatively straightforward. However, this is not the place to start the conversion. The regulations from Title 21 of the Code of Federal Regulations Part 117 (21 CFR 117) are much more comprehensive than HACCP regulations in the type of documentation needed. Thus, the best starting point for the conversion is asking yourself a much simpler question: Do I have the appropriate food safety system?

Related: The ABCs Of Building A Food Safety Plan

Back To Prerequisite Programs
Understanding the Subparts of the regulation, codified under 21 CFR 117, helps focus on which areas to cover first. The Subparts are:

Subpart A — General Provisions

Subpart B — Current Good Manufacturing Practice (cGMP)

Subpart C — Hazard Analysis and Risk-Based Preventive Controls (HARPC)

Subpart D — Modified Requirements                                                                            

Subpart E — Withdrawal of a Qualified Facility Exemption

Subpart F — Requirements Applying to Records That Must Be Established and Maintained

Subpart G — Supply-Chain Program