For the purposes of this Regulation, the following definitions shall apply:
(a)
‘good distribution practice for active substances used as starting materials in veterinary medicinal products’ means the part of the quality assurance throughout the supply chain which ensures that the quality of active substances used as starting materials in veterinary medicinal products is maintained throughout all stages of the supply chain from the site of their manufacturer to the manufacturers of veterinary medicinal products;
(b)
‘quality system’ means the sum of all aspects of a system that implements quality policy and ensures that quality objectives are met;
(c)
‘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 an active substance used as a starting material in veterinary medicinal products across the substance’s lifecycle;
(d)
‘procuring’ means obtaining, acquiring or purchasing active substances used as starting materials in veterinary medicinal products from manufacturers, importers or other distributors;
(e)
‘holding’ means storing active substances used as starting materials in veterinary medicinal products;
(f)
‘supplying’ means all activities of providing, selling or donating active substances used as starting materials in veterinary medicinal products to distributors, pharmacists, manufacturers of veterinary medicinal products, or other persons in accordance with national law;
(g)
‘deviation’ means departure from approved documentation or an established standard;
(h)
‘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 active substances used as starting materials in veterinary medicinal products;
(i)
‘distribution of active substances used as starting materials in veterinary medicinal products’ means all activities consisting of procuring, importing, holding, supplying or exporting of active substances used as starting materials in veterinary medicinal products;
(j)
‘documentation’ means written procedures, instructions, contracts, records and data, in paper or in electronic form;
(k)
‘signed’ means the record of the individual who performed a particular action or review. This record can be initials, a full handwritten signature, a personal seal, or an advanced electronic signature as defined in Article 3(11) of Regulation (EU) No 910/2014 of the European Parliament and of the Council ( 6 ) ;
(l)
‘expiry date’ means the date placed on the container or labels of an active substance used as a starting material in veterinary medicinal products designating the time during which that active substance is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used;
(m)
‘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;
(n)
‘retest date’ means the date when an active substance used as a starting material in veterinary medicinal products should be re-examined to ensure that it is still suitable for use;
(o)
‘transport’ means moving active substances used as starting materials in veterinary medicinal products between two locations without storing them for unjustified periods of time;
(p)
‘batch number’ means a distinctive combination of numbers or letters that uniquely identifies a batch;
(q)
‘contamination’ means the undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or active substance during production, sampling, packaging or repackaging, storage or transport;
(r)
‘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;
(s)
‘quarantined’ means the status of materials isolated physically or by other effective means pending a decision on approval or rejection;
(t)
‘qualification’ means the action of proving that any equipment works correctly and actually leads to the expected results;
(u)
‘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;
(v)
‘falsified active substance used as a starting material in veterinary medicinal products’ means any active substance used as a starting material in veterinary medicinal products with a false representation of any of the following:
(i)
its identity, including its packaging and labelling, its name or its components as regards any of the ingredients and the strength of those ingredients;
(ii)
its source, including its manufacturer, its country of manufacturing, its country of origin; or
(iii)
its history, including the records and documents relating to the distribution channels used.
