Sampling
Article 34
1. A sampling plan shall be established, which shall take into account the risks to the quality of the veterinary medicinal product and address the different materials used in the manufacturing process as well as the various stages of production. 2. Samples shall be representative of the batch of materials or products from which they are taken. The sample taking shall be done in accordance with written procedures that describe at least the following: (a) the amount of sample to be taken; (b) equipment and containers to be used; (c) precautions to be observed to prevent contamination; (d) other precautions to be observed, in particular in the case of sterile or noxious materials; (e) storage conditions for the samples taken; (f) the cleaning instructions for the equipment used. 3. Personnel in charge of taking samples shall receive training on the following: (a) techniques and equipment for sampling; (b) the risks of cross-contamination; (c) precautions to be taken with regard to unstable or sterile substances; (d) the need to record any unexpected or unusual circumstance; (e) other aspects relevant to the implementation of the sampling procedures. 4. Sample containers shall bear a label indicating the content, batch number, date of sampling and containers from which the samples have been taken. When containers are too small, the use of bar-codes or other means that permit access to that information may be considered. Sample containers shall be handled and stored in a way that minimises the risk of mix-up or the deterioration of their content. The storage conditions set out in the marketing authorisation shall be applied. 5. Samples shall be kept at the disposal of the competent authorities for the following periods: (a) Reference samples and/or retention samples from each batch of finished product shall be retained for at least one year after the expiry date. The reference sample shall be contained in its finished immediate packaging. However, in the case of large volume presentations, where it is not feasible to retain samples from each batch in its final packaging, the manufacturer shall ensure that sufficient representative samples of each batch are retained and that the container used for storage is composed of the same material as the immediate container in which the product is marketed. (b) Reference samples of materials used in the manufacture of veterinary medicinal products, other than solvents, gases or water, shall be kept for at least two years after the release of the product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. (c) Samples of packaging materials shall be kept for the duration of the shelf-life of the finished product concerned. For this purpose, retention of printed materials as part of the reference and/or retention samples is also acceptable. For finished products, reference and retention samples may be regarded as interchangeable. 6. Reference samples shall be of sufficient size to permit the carrying out on at least two occasions of the full analytical controls on the batch in accordance with the marketing authorisation. 7. In cases when the marketing authorisation holder is not the entity responsible for batch release or when several sites are responsible for the manufacture or batch release, the responsibility for the taking and storing of reference and retention samples shall be defined in writing. 8. The ability to do relevant testing throughout the shelf-life of the veterinary medicinal product shall be ensured.