Personnel Qualification, Training, Responsibility Requirements

  • The management of an establishment is required to:

  • Ensure that all individuals who manufacture, process, pack, or hold animal Food subject to the CGMPs are qualified to preform their assigned duties.

  • Ensure that the CGMP requirements of 21 CFR part 507, subpart B are followed for all animal Food manufacturing, processing, packing, and holding operations (including receiving, inspecting, transporting, and segregating).

  • Ensure that the overall cleanliness of the plant is under the supervision of one or more competent individuals assigned responsibility for the function.

  • Responsibility for ensuring compliance by individuals with the requirements of 21CFR507 must be clearly assigned to supervisory personnel who have the education, training, or experience (or combination thereof) necessary to supervise the production of sAfe animal food.

  • Individuals who supervise or perform manufacturing, processing, packing or holding activities must:

  • Be a QI (i.e., have the education, training, or experience, or combination thereof) necessary to manufacture, process, pack, or hold safe animal food ad appropriate to the individual’s assigned duties.

  • Receive training in the principles of animal food hygiene and animal food safety.

  • Requirements must be met even if the individuals only works on a temp or seasonal basis.

  • Training in the principles of animal food hygiene and animal food safety must include information on the importance of employee health and personal hygiene, but the appropriate scope of training depends on the animal food, facility, and assigned duties.

  • Facilities are required to keep records that document this training.

Personal Hygienic Practice Requirements

  • Management of the establishment must take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food contact surfaces, and animal food packing materials conform to hygienic practices as necessary to protect against the contamination of animal food.

  • Methods include:

  • Maintaining adequate personal cleanliness

  • Washing hands thoroughly in an adequate hand-washing facility as necessary and appropriate to protect against contamination.

  • Removing or securing jewelry and other objects that might fall into animal food, equipment, or containers.

  • Storing clothing and personal belongings in areas other than where animal food is exposed or where equipments and utensils are cleaned.

  • Taking any other necessary precautions to protect against the contamination of animal food, animal food contact surfaces, or animal food packaging materials.

Plant Construction, Design, and Maintenance Requirements

  • A plant must be suitable in size, construction and design to facilitate cleaning, maintenance, and pest control to reduce the potential for contamination of animal food animal food contact surfaces, and animal food packaging materials.

  • Buildings, structures fixtures, and other physical facilities of the plant must be kept clean and in good repair to prevent animal food from being adulterated.

  • There must be adequaTe space between equipment, walls, and stored materials to allow for cleaning and maintenance of equipment and other employee duties.

  • The plant must be constructed in a way that drip or condensate from fixtures, ducts, and pipes are not a source of contamination.

  • Adequate ventilation must be provided where necessary and appropriate to minimize vapors and fumes in areas where they may contaminate animal food. When ventilation’s is used to remove capris and fumes in the animal food plant, it may be done in a way that minimizes the potential for contamination of animal food.

  • The plant must have adequate lighting in hand washing areas, toilet rooms, areas where animal food is received, manufactured, processed, packed, or held, and areas where equipment or utensils are cleaned.

  • Light bulbs, fixtures skylights, or other glass items suspended over exposed animal food must be shatter resistant to protect against the contamination of animal food from glass breakage.

Grounds and Outdoor Animal Food Storage Requirements

  • Grounds around a plant under control of the management of the establishment must be kept in a way that will protect against the contamination of the animal food.

  • Maintenance grounds must include:

  • Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may attract, harbor, or serve as a breeding place for pests.

  • Maintaining driveways, yards, and parking areas so they are not a source of contamination for exposed animal food.

  • Adequately draining areas that may contribute to continuation of animal food.

  • Treating and disposing of waste so that it does not become a source of contamination in areAs where animal food is exposed.

  • If an animal food plant stores bulk animal food or ingredients outside, it must protect the animal food from contamination by any effective means including:

  • Using protective coverings where necessary and appropriate.

  • Controlling areas over and around the bulk animal food to eliminate harborage for pests.

  • Checking on a regular basis for pests, pest infestation and a product condition related to the safety of the animal food.

Sanitation Requirements

  • All surfaces (food-contact and non-contact) of utensils and equipment must be cleaned and maintained. Utensils and equipment are to be stored to protect against contamination of animal food, animal food contact surfaces, or animal food packaging materials. When necessary, equipment must be disassembled for thorough cleaning.

  • If animal food contact surfaces are wet cleaned, the surfaces must be thoroughly dried before subsequent use, when necessary.

  • In wet processing, it may be necessary to clean and sanitize to protect against the introduction of undesirable microorganisms into the animal food. If so, all animal food contact surfaces must be cleaned and sanitized before use, and after any interruption during which the animal food contact surfaces may have become contaminated.

  • When compressed air or other gases mechanically introduced are used in animal food or used to clean animal food contact surfaces, or equipment, it must be used in a way that protects against the contamination of animal food.

  • Management of the establishment must ensure that chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures.

  • Regardless of the type of animal food plant, cleaning compounds and sanitizing agents must be safe and adequate under the conditions of use. The only toxic materials that may be used or stored in the area of the re animal food is manufactured, processed, or exposed are those that are needed for cleaning and sanitizing, plant and equipment maintenance and operations, laboratory testing procedures, and use in the plant’s operations.

  • These toxic materials must be identified, used, and stored in a manner that protects against the contamination of animal food, animal food contact surfaces, or animal food packaging materials.

  • Other toxic materials such as fertilizers and pesticides not needed for cleaning and sanitizing, plant and equipment maintenance and operation, lab testing procedures, or use in the plant’s operations must be stored only in areas of the plant where animal food is not manufactured, processed, or exposed.

  • Effective measured must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of animal food by pests. Pesticides may be used in the plant only under precautions and restrictions that will protect against the contamination of animal food animal food contact surfaces, and animal food packaging materials.

  • Trash must be conveyed, stored and disposed of in such a way that protects against the contamination of animal food, animal food contact surfaces, or animal food packaging materials, water supplies and ground surfaces, and minimizes the potential for trash to attract or harbor pests or serve as a breeding place for pests.

Water Supply and Plumbing Requirements

  • Water used by the plant must be adequate for the operations and derived from an adequate source.

  • Water that contacts animal food, animal food contact surfaces, or animal food packaging materials must be sAfe for its intended use.

  • Water may be reused for washing, rising, or conveying animal food if it does not increase the level of contamination of the animal food.

  • Any ice that is used in contact with animal food must be made from water that is safe and has been manufactured in accordance with the 21 CFR part 507 CGMPs.

  • Running water at a suitable temperature and under suitable pressure as needed must be provided in all areas where it is required for the manufacturing, processing packing, or holding of animal food, for the cleaning of equipment, utensils, and animal food packaging materials, or for employee hand washing facilities.

  • Plumbing must be designed, installed and maintained to carry adequate quantities of water to required locations throughout the plant and properly convey sewage and liquid disposable waste from the plant.

  • Plumbing must be designed, installed and maintained to alive being a source of contamination to the animal food, water supplies, equipment, or utensils and to avoid creating an unsanitary condition.

  • Plumbing must be designed, installed and maintained so that there is no backflow and there is no cross-connection between discharge pipes and pipes that carry water from animal food or animal food manufacturing.

  • Plumbing must be designed, installed and maintained in a way that provides adequate floor drainage in all areas where flooding-type cleaning is used on floors or where normal operations release a or discharge water or other liquid waster on the floor.

  • Sewage and liquid waste must be disposed of through an adequate sewage system or through other adequate means.

  • Each plant must provide employees with adequate, readily accessible toilet facilities.

  • Toilet facilities must be kept clean and must not be a potential source of contamination of animal food, animal food contact surfaces, or animal food packaging materials.

  • Each plant must provide hand washing facilities designed to ensure that an employee’s hands are not a potential source of contamination of animal food, animal food contact surfaces, or animal food packaging materials.

Equipment and Utensil Requirements

  • All plant equipment and utensils that are used in manufacturing, processing, packing, and holding animal food (including those that do not come into contact with animal food) must be designed and constructed of material and workmanship to be adequately cleanable and must be properly maintained.

  • Equipment and utensils used in manufacturing, processing, packing, and holding animal food must be designed, constructed, and used so that they do not adulterate the animal food with non-food grade lubricants, fuel, metal fragments, contaminated water, or any other contaminants.

  • Equipment must be installed to facilitate cleaning and maintenance of the equipment and adjacent spaces.

  • Animal food contact surfaces must be:

  • Made of materials that withstand the environment of their use, the action of animal food, and, if applicable, the action of cleaning compounds and procedures and sanitizing agents.

  • Made of nontoxic materials

  • Maintained to protect animal food from contamination

  • Holding, conveying manufacturing and processing systems must be designed, constructed, and maintained in a way to protect against the contamination of animal food.

  • These types of systems include gravimetric, pneumatic, closed, and automated systems.

  • Each freezer and cold storage compartment used to hold animal food must be fitted with an accurate temperature measuring device.

  • Instruments and controls used for measuring regulating, or recording temperatures, pH, aw, or other conditions that control or prevent the growth of undesirable microorganisms in animal food must be accurate, precise, adequately maintained and adequate in number for their designed uses.

Ingredient Receiving Requirements

  • Shipping containers (e.g. totes, drums, and tubs) and bulk vehicles holding raw materials and another ingredients must be examined upon receipt to determine whether contamination or deterioration of animal food has occurred.

  • Raw materials and other ingredients must be examined toe ensure they are suitable for manufacturing and processing into animal food.these materials and other ingredients must be handled under conditions that will protect against contamination and minimize deterioration.

  • Raw materials must be cleaned as necessary to minimize contamination.

  • If raw materials and other ingredients are suspect able to contamination with mycotoxins or other natural toxins, they must be evaluated and used in a way that does not result in an animal food that can cause injury or illness to animals or humans.

  • When an incoming raw material or other ingredient is received frozen. It must be kept frozen or thawed in a way that minimizes the potential for growth of undesirable microorganisms.

Manufacturing and Processing Requirements

  • Management must ensure that adequate precautions are taken so that plant operations do not contribute to the contamination of animal food, animal food contact surfaces, and animal food packaging materials.

  • Raw materials rework, and other ingredients must be stored in contained designed and constructed to protect against contamination and deterioration and held under conditions that will minimize the potential for growth of undesirable microorganisms and prevent the animal food from becoming adulterated.

  • Manufacturing and processing steps such as cutting, drying, deflating, grinding, mixing, extruding, pelleting, and cooling must be done in a way that protects against the contamination of the animal food.

  • Filling, assembling, packaging, and other operations must be done in a way that protects against the contamination of animal food and the growth of undesirable microorganisms.

  • Management must ensure that chemical, microbial, or extraneous material testing procedures are used where necessary to identify possible animal food contamination.

  • Management must ensure that all manufacturing, processing, packing, and holding is conducted under such conditions and controls as are necessary to minimize the potential for the growth of undesirable microorganisms in order to protects against the contamination of the animal food.

  • During manufacturing processing, packing, and holding operations. The animal food must be maintained under a conditions that will minimize the potential for growth of undesirable microorganisms and prevent the animal food from becoming adulterated.

  • Work in process and rework must be handled in a way that protects against contamination and the growth of undesirable microorganisms.

  • When a plant is using measures such as heat treating freezing, refrigerating, irradiating, controlling pH, or controlling as to significantly minimize or prevent the growth of undesirable microorganisms during manufacturing, processing packing, and holding, those measure must be adequate to prevent the adulteration of animal food.

  • When water activity (aw) is used to prevent the growth of undesirable microorganisms, the animal food must be processed to and maintained at a safe aw level.

  • When pH is used to prevent the growth of undesirable microorganisms, pH must be monitored, and the appropriate pH level must be maintenance in the animal food.

  • Management of the establishment must ensure that animal food is accurate identified.

  • When animal food has become adulterated, management of the establishment must ensure that it is rejected, disposed of, or if appropriate it is treated or processed to eliminate the adulteration.

  • Disposal must be done in a way that protects against the contamination of other animal food.

Packaging, Holding, and Distribution Requirements

  • Management of the establishment must ensure animal food packaging materials are safe and suitable.

  • When animal food is held for distribution, it must be held under conditions that will protect it from contamination and minimize deterioration. Including:

  • If container are used to hold animal food before distribution, they must be designed and constructed of appropriate material, cleaned as necessary, and maintained in a way that protects against the contamination of animal food.

  • Animals food must be held in a way that protects against contamination from sources such as trash.

  • Th labeling for the animal food product ready for distribution must contain, when applicable, information and instructions for safety using the product for the intended animal species.

  • When the facility is responsible for transporting the animal food itself or arranges with a third party to transport the animal food, the shipping contained (e.g. totes, drums, and tubs) and bulk vehicles used to distribute animal food must be examined prior to use to protect against the contamination of animal food from the container or vehicle.

  • Unpackaged or bulk animal food must be held for distribution in a way that does not result in unsafe cross contamination with other animal food.

  • Returned animal food must be identified as such and serrated until assessed for animal food safety to determine the appropriate disposition.

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