Pet Food & Animal Feed Procedure

Control approval against intended use, species and market legislation

Before a new or modified product is approved for routine manufacture, the procedure requires its intended feeding use, intended animal species and intended countries of sale to be established. Product Development Personnel develop the formulation against those requirements, while Technical / Quality Management confirms formulation suitability, species restrictions and the legal requirements or restrictions that apply in the country of production and each intended country of sale.

The legislative assessment is retained within the development pack, and requirements needed for routine control are transferred into the affected specification, recipe, label, production instruction, packing instruction or disposal instruction before approval for routine manufacture. Sales / Commercial Personnel may target only countries confirmed as acceptable by Technical / Quality Management; a proposed new market for an existing product must be assessed before the product is offered for sale there.

Intended use is also defined at product level. The procedure requires consideration of feeding use, consumption frequency, nutritional composition, portion size and other characteristics that affect the defined use, with the approved position retained in the development pack and product specification before routine manufacture.

Separate species suitability from rework compatibility

Where products are made for more than one animal species, the procedure requires ingredients, raw materials, processing aids, development ingredients, intermediate products, finished products and rework that could harm an unintended species to be identified and controlled. Technical / Quality Management determines species restrictions, and the permitted species and restrictions on use are carried into the controlled information used for receipt, storage, issue, formulation, manufacture and packing.

Rework is given a separate compatibility decision rather than being treated as automatically reusable. It is identified by source product and intended species and assigned restricted status until Technical / Quality Management records whether it is compatible with the proposed receiving product. If compatibility is not confirmed, the rework remains unavailable for use and is controlled under the Non-Conforming Product Control Procedure.

Where harmful carry-over could occur between products for incompatible species, the required control is defined and incorporated into the relevant production-scheduling, segregation, line-clearance or cleaning instruction. The procedure therefore makes species suitability, rework compatibility and carry-over prevention distinct control decisions.

Identify and control medicated materials throughout handling

For medicated raw materials, both the material and its supplier must hold approved status before use. Technical / Quality Management confirms that approval from the relevant records; material with unapproved, expired or uncertain approval status remains unavailable for issue or use.

The control extends beyond raw materials. Medication-containing processing aids, intermediate products, finished products, rework and product-development ingredients must remain identifiable while handled on site. Identification shows that medication is present, identifies the medicinal substance and distinguishes between different medicinal substances where more than one is handled.

Technical / Quality Management defines the identification, storage, segregation and handling requirements needed to prevent confusion, unintended use or contamination, and those requirements are incorporated into the controlled instructions used for the affected activity. Medication-containing materials and products remain identifiable through receipt, storage, issue, manufacture, packing, handling and disposal, with traceability maintained through the wider FSQMS traceability controls.

Validate medicinal-substance concentration and distribution

The procedure develops medicinal-substance control from formulation through validation. Product Development Personnel, in consultation with Technical / Quality Management, establish the quantity of each medicinal substance required, considering the intended dose, batch size and processing effects that could alter finished-product concentration. Technical / Quality Management approves the target concentration and the acceptance criteria for both concentration and distribution through the batch.

Existing validation evidence can be accepted only after a recorded comparability assessment has considered the formulation, medicinal substance, equipment, batch size, manufacturing process and operating conditions. Where that evidence cannot be accepted, the production method is validated before routine manufacture to demonstrate that the approved formulation achieves the specified concentration and that the process distributes the medicinal substance through the batch within the approved criteria.

Routine production then uses the approved recipe and production instruction, with retained weighing, dispensing or batch-manufacturing records identifying the medicinal substance, authorised quantity, product, batch and completed addition or dispensing activity. Where analytical results are established as a condition of product release, the product remains unreleased until the required testing and review are complete and the approved criteria have been met; analytical positive release is not applied universally.

Control contamination routes before manufacture

Technical / Quality Management identifies where medicinal substances could contaminate non-medicated materials or products during receipt and storage, internal movement, weighing or dispensing, processing, rework handling, packing, cleaning or waste handling. The identified routes and selected controls are recorded in the affected specification, instruction or documented contamination assessment.

Depending on the route, controls may include physical segregation, controlled material movement, production sequencing, line clearance, dedicated equipment or utensils, or cleaning. Where the proposed controls cannot be demonstrated to prevent transfer to the applicable legal and product-specification requirements, the product or process is not approved for manufacture until it has been redesigned.

When sequencing or line clearance is used, completion is recorded before the following non-medicated product is introduced. Where cleaning is required, the affected equipment, production area or transfer route is not returned to non-medicated use until cleaning, verification and release have been completed under the Housekeeping & Hygiene Procedure.

Keep labelling, release and disposal tied to approved requirements

For medicated products, Technical / Quality Management defines the required label information, including the medicinal substance, intended animal species, limitations on use, instructions or warnings needed for safe use and other information required by legislation or the approved product specification. Label-content verification and artwork approval sit with the Product Labelling & Artwork Control Procedure, while packing-stage issue, application and checks are governed by the Labelling & Pack Control Procedure.

The procedure also distinguishes formulation control from product release. Analytical testing and positive release apply only where legislation, the approved product specification or a customer requirement has established analytical release criteria. Disposal of medicated raw materials and products is required to be safe and legal, with the detailed waste-disposal process governed by the Waste & Waste Disposal Procedure.

Define responsibilities, deviations and FSQMS interfaces

Responsibility is allocated across the functions that make and apply the key decisions. Senior Management provides the resources and organisational authority needed for implementation. Technical / Quality Management owns the technical assessments for legislation, intended species, formulation suitability, rework compatibility, medication-specific controls, validation evidence, release criteria, labelling requirements and disposal restrictions. Product Development Personnel establish intended use, species and markets and develop formulations to the confirmed requirements, while Sales / Commercial, Warehouse / Stores, Production / Operations and Packing Personnel apply the approved restrictions and instructions within their activities.

The procedure also contains a defined response when controls fail. Loss of identification or traceability, incorrect species use, rework incompatibility, medicinal-substance addition error, loss of approval status, contamination concerns, labelling discrepancies and disposal concerns are reported to Technical / Quality Management. Where material or product may have been affected, it is prevented from use, packing, release or dispatch and controlled under the Non-Conforming Product Control Procedure. Corrective and preventive action, and any escalation for released product or product-safety or legal risk beyond direct site control, are then managed through the relevant FSQMS procedures.

These interfaces are deliberate boundaries. Product development and validation, supplier approval, specifications, physical segregation, cleaning verification, laboratory analysis, product release, routine manufacture, traceability, non-conforming product control and incident management remain governed by their specialist procedures. The Pet Food & Animal Feed Procedure defines the pet-food and animal-feed requirements that those wider controls must support.