How Does this Guidance Relate to Our Current Good Manufacturing Practice Regulations in 21 CFR Part 110?
In Title 21 of the Code of Federal Regulations (21 CFR part 110), we have established regulations for current good manufacturing practice (CGMP) in preparing, packing or holding food. These regulations include both binding requirements and non-binding recommendations relating to personnel, buildings and facilities, equipment, and production and process controls. In general, 21 CFR part 110 uses the word “shall” to identify binding requirements and the word “should” to identify non-binding recommendations. For example, under 21 CFR 110.80(a)(1), raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Containers and carriers of raw materials should be inspected on receipt to e
