Example text from my allergen SOP. We have an allergen-free facility.
a. All manufacturing and label design activities that could be exposed/affected by the FDA “big 8” allergens:
b. Allergens currently present in facility: no ingredients including allergens are utilized at company at this time.
c. Company currently does not perform rework that would create a risk of cross-contamination or labeling error.
a. Employees responsible for all activities which involve the declaration or handling of ingredients containing allergens are responsible for carrying out those tasks within the guidelines recorded in this document.
a. This SOP shall be revised if/when company begins utilizing ingredients that contain any of the allergens listed above.
b. Company is committed to ensuring label accuracy by following all requirements of the food allergen labeling and consumer protection act of 2004.
c. Label accuracy shall be ensured through initial label development review, and correct assignment of labels shall be verified by operators at time of packaging.
d. Employee GMP and Food safety training will include allergen awareness and cross contamination principals.
e. Ongoing verification of allergen status of ingredients will be completed using the vendor approval process.
i. Suppliers will identify if any “big 8” allergens are present in products purchased by Company.
f. While there are no ingredients with “big 8” allergens in the facility, there is no applicable procedure for the validation of allergen removal with analytical testing.