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Production and Process Control

This subpart describes the most detailed requirements. It includes a large section on processes and controls and a small section on warehousing and distribution.

The section on processes and controls has two major subdivisions: (a) raw materials and other ingredients; and (b) manufacturing operations. The first subsection has descriptions of required inspection, storage and handling of ingredients. Specific information regarding the treatment of ingredients subject to microbiological activity and the handling of ingredients subject to aflatoxin or other toxins is provided. Requirements on storage of frozen raw materials and ingredients, and bulk liquid and dry ingredients are also given. The manufacturing operations subsection requires conditions and controls necessary to minimize the potential for growth of microorganisms, or for the contamination of food. Monitoring of factors such as time, temperature, humidity, water activity, pH, pressure and flow rates is important for the control of conditions. The following requirements for holding foods are given in this subsection:

(a) Refrigerated foods must be kept at or under 45' F (7.2 0 C) as appropriate for the particular food involved.
(b) Frozen foods must be maintained in a frozen state.
(c) Hot foods must be kept at or above 140o F (60o C).

The manufacturing operations subsection also requires the establishment of measures that prevent the finished food product from contamination by raw materials, other ingredients, refuse and metal or other foreign materials.

The section on warehousing and distribution requires that the transportation and storage operations are conducted under conditions that prevent physical, chemical and microbiological contamination.

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