“Obtaining and evaluating and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.” – 21 CFR 117.3.  In short, validation establishes the scientific basis for process preventive controls in the food safety plan by a Preventive Controls Qualified Individual (PCQI). A PCQI must perform or oversee validation and most verification activities.

When is validation required?

  • A facility has a Critical Control Point (CCP) or process preventive control (PC).
  • Before the food safety plan is implemented, or
  • Within the first 90 calendar days of production, or
  • Within a reasonable timeframe with written justification by the PCQI.
  • A change in control measure(s) could impact process efficacy.
  • Reanalysis of the food safety plan indicates the need.

Validation Exceptions: 

Validation of allergen clean. 

The Preventive Controls for Human Food regulation does not mandate validation of food allergen controls, sanitation controls, the supply‐chain program or the recall plan. However, product recalls have been associated with undeclared allergens in products, thus validated cleaning procedures for difficult to clean equipment may be useful to assure that the procedures are effective in removing allergen residues.

Validation of extended run time before cleaning. 

Validation of the effectiveness of sanitizers to kill pathogens is conducted when the chemical manufacturer registers the product with the Environmental Protection Agency (EPA) or similar regulatory agencies in other countries. This validation demonstrates effectiveness of the sanitizer or sterilant when used according to label instructions and it is a violation of federal law to use such products in a manner that is not consistent with the label. Thus, following label instructions on registered sanitizers and sterilants is the first step in validation. Suppliers of cleaners and sanitizers often validate these products with respect to cleaning particular soils and eliminating certain pathogens, thus following their established procedures is also important. A facility may choose to validate that the frequency of cleaning is adequate to control hazards in their operation to prevent product safety issues.

Justification for not validating a CCP or process PC.

Written justification that validation is not applicable to a preventive control may be prepared by the PCQI. This may be based on factors such as the nature of the hazard, the nature of the preventive control and its role in the food safety system.

Validation Services

  • Thermal Process Authority
  • In‐plant validation testing of CCPs or process PCs
  • Research of scientific literature for validation studies applicable to your facility
  • Use of mathematical models for validation
  • In-plant validation of allergen clean
  • In-plant validation of extended run time before cleaning

ConnectFood partners have experience with high pressure processing, acidified foods, and aseptic processing. ConnectFood Partners are not only PCQIs, but Lead Instructors of PCQIs, who can work with your staff to write justification for extended time frames on validation studies or justification for not validating a CCP or process PC.