- airlock
means an enclosed space with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards).
- area
means a space.
- aseptic processing/manufacturing
means processing or manufacturing activities performed under conditions which prevent contamination;
- batch
means a defined quantity of materials or product that undergo the same process(es) so that it can be expected to be homogeneous.
- bracketing
means an approach such that only the extremes of certain predetermined factors are tested or validated.
- bulk product
means any product which has completed all processing stages up to, but not including, final packaging;
- campaign manufacture
means the manufacture of a series of batches of the same product in sequence in a given period of time followed by strict adherence to preestablished control measures before transfer to another product.
- clean area
means an area designed, maintained, and controlled to prevent particle and microbiological contamination;
- closed system
means a system designed and operated so as to avoid exposure of the product or material to the room environment.
- contained area
means an area that is designed (including air handling and filtration), maintained and controlled so as to prevent contamination of the external environment by biological or other agents;
- cross-contamination
means the contamination of a material or a product with another material or product;
- finished product
means a veterinary medicinal product that has undergone all the stages of production, including packaging in its final container;
- in-process controls
means the checks performed during production in order to monitor and, if necessary, adjust the process to ensure that the product conforms to the required specifications.
- intermediate product
means a partly processed material which must undergo further manufacturing steps before it becomes a bulk product;
- isolator
means an enclosure capable of being subject to reproducible interior bio-decontamination, with an internal work zone meeting grade A conditions that provides uncompromised, continuous isolation of its interior from the external environment (e.g. surrounding cleanroom air and personnel).
- manufacturing site
means a site that is engaged in any of the activities for which a manufacturing authorisation is required in accordance with Article 88(1) of Regulation (EU) 2019/6;
- matrix
means an approach where a subset of the total number of possible samples for all factor combinations is tested at a specified time point and another subset of samples is tested for all factor combinations at a subsequent time point.
- packaging
means all operations, including filling (with the exception of sterile filling) and labelling, which a bulk product has to undergo in order to become a finished product;
- packaging material
means any material employed in the packaging of a veterinary medicinal product, excluding any outer packaging used for transportation or shipment.
- pharmaceutical quality system
means the total sum of the measures implemented as part of the manufacturing process to ensure that medicinal products are of the quality required for their intended use;
- qualification
means the process of demonstrating that entities, premises, equipment, utilities, systems or materials are suitable for the intended task and can deliver the expected outcomes;
- quality risk management
means a systematic process, applied both proactively and retrospectively, for the assessment, control, communication and review of risks to the quality of the veterinary medicinal product across the product’s lifecycle;
- quarantine
means the isolation – physically or by other effective means – of materials, intermediate, bulk or finished products whilst awaiting a decision on their release or refusal;
- reconciliation
means a comparison, having due regard for normal variation, between the amount of product or materials theoretically and actually produced or used;
- reference sample
means a sample of a batch of materials used in the manufacture of a veterinary medicinal product or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned;
- reprocessing
means the treatment of all or part of a batch of product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations;
- retention sample
means a sample of a fully packaged unit from a batch of finished product which is stored for identification purposes;
- segregated area
means an area within a manufacturing site that has separate storage, separate production suite with separate HVAC (heat, ventilation and air conditioning), dedicated equipment reserved solely for the production of one type of product with a specific risk profile and restrictions on the movement of personnel and equipment;
- signed
means the record of the individual who performed a particular action or review.
- validation
means the process of demonstrating that a method or process is suitable for its intended use;