- batch
means a defined quantity of starting material, packaging material or product processed in a single process or series of processes, so that it is expected to be homogeneous;
- batch number
means a distinctive combination of numbers or letters that uniquely identifies a batch.
- calibration
means the set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard;
- contamination
means the undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a veterinary medicinal product during production, sampling, packaging or repackaging, storage or transport;
- customs warehouse
means any of the warehouses referred to in Article 240(1) of Regulation (EU) No 952/2013;
- deviation
means departure from approved documentation or an established standard;
- documentation
means written procedures, instructions, contracts, records and data, in paper or in electronic form;
- expiry date
means the date placed on the packaging of a veterinary medicinal product designating the time during which that veterinary medicinal product is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used;
- falsified veterinary medicinal product
means any veterinary medicinal product with a false representation of any of the following:
- free zone
means any free zone designated by the Member States in accordance with Article 243 of Regulation (EU) No 952/2013 of the European Parliament and of the Council;
- good distribution practice for veterinary medicinal products
means the part of the quality assurance throughout the supply chain which ensures that the quality of veterinary medicinal products is maintained throughout all stages of the supply chain from the site of their manufacturer to the persons referred to in Article 101(2) of Regulation (EU) 2019/6;
- holding
means storing veterinary medicinal products;
- procedure
means a documented description of the operations to be performed, the precautions to be taken and measures to be applied directly or indirectly related to the distribution of veterinary medicinal products;
- procuring
means obtaining, acquiring or purchasing veterinary medicinal products from manufacturers, importers or other wholesale distributors;
- qualification
means the action of proving that any equipment works correctly and actually leads to the expected results;
- 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;
- quality system
means the sum of all aspects of a system that implements quality policy and ensures that quality objectives are met;
- signed
means the record of the individual who performed a particular action or review.
- supplying
means all activities of providing, selling or donating veterinary medicinal products to the persons referred to in Article 101(2) of Regulation (EU) 2019/6;
- transport
means moving veterinary medicinal products between two locations without storing them for unjustified periods of time;
- validation
means a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria;