Order No. 125/2016 of the National Sanitary Veterinary and Food Safety Authority validating the Veterinary Sanitary Regulation regarding the methodology of sampling, packaging, identification, storage and transport of samples of veterinary medicinal products in order to perform laboratory control.

Veterinary Sanitary Regulation regarding the methodology of sampling, packaging, identification, storage and transport of samples of veterinary medicinal products in order to perform laboratory control is applicable to all persons responsible for sampling, packaging, identification, storage and transport of samples of veterinary medicinal products for the performance of laboratory control. The collection of samples of veterinary medicinal products is performed for the following purposes: (a) quality testing for post-authorization supervision; (b) quality verification, during good manufacturing inspections; (c) verification of immunological products used in mandatory veterinary sanitary applications; (d) suspicions regarding quality defects, safety and efficacy; (e) suspicions of counterfeit, false or illegal products; (f) confirmation of quality defects; and (g) confirmation of the results exceeding the admissibility limits. The samples taken can be: (a) raw materials used in the manufacturing process of finished veterinary medicinal products; (b) intermediate products used in the manufacturing process; (c) pharmaceutical products and intermediate and finished immunological products on the flow of production, before and after packaging or before and after marketing; and (d) primary and secondary packaging materials. Samples are taken from each batch and is verified separately. During the sampling and preparation of laboratory samples, measures are taken to avoid any contamination and damage that could affect analytical results. Each sample is taken at random from the lot. The taking of the sample is carried out on the basis of a report of sampling, completed and signed by the person responsible for sampling and countersigned by a representative of the unit where the sampling is performed. All samples must be packed, sealed and transported properly, so as to avoid their destruction and contamination. The samples taken shall be kept in adequate safety conditions, in accordance with the storage conditions specified for that pharmaceutically active ingredient, excipient or medicinal product.