Certification and batch release
Article 39
1. Batches of veterinary medicinal products can only be released for sale or supply to the market after a qualified person certifies – by means of a control report– that each batch of a veterinary medicinal product has been manufactured and tested in accordance with the requirements of the marketing authorisation and good manufacturing practice. Certification can only be performed by the qualified person of a manufacturer described in the marketing authorisation. A model template for batch release certificate is provided in Annex VIII. 2. Reliance by the qualified person on real time release testing or parametric release is only possible if the conditions and requirements laid down in Annex IX are met. 3. Evidence of the certification referred to in paragraph 1 shall be recorded by the qualified person in a register or equivalent document provided for that purpose. That register or equivalent document shall be kept up to date and shall remain at the disposal of the competent authority for one year after the expiry of the batch to which it relates or at least five years after certification of the batch by the qualified person, whichever is longer. 4. The qualified person who performs the certification of the batch of a veterinary medicinal product may assume full responsibility for all stages of manufacture of the batch or may share this responsibility with other qualified persons who have confirmed compliance of specific steps in the manufacture and control of a batch. If a manufacturing site only undertakes partial manufacturing operations, the qualified person at that site shall, at least, confirm that the operations undertaken at that manufacturing site have been performed in accordance with good manufacturing practice and the terms of the written agreement detailing the operations for which the manufacturing site is responsible. Partial manufacturing shall only occur in a manufacturing site authorised in accordance with the terms of the marketing authorisation. A model template for confirmation of partial manufacturing is provided in Annex VIII. 5. Where various batches of finished product originate from the same batch of bulk product, certification of the different batches of finished product may be based on the quality control testing of a previously certified batch provided that this is justified based on quality risk management principles. The following elements shall at least be verified by the qualified person: (a) the relevant requirements for storage of the bulk product prior to packaging have been complied with; (b) the batch of the finished product has been stored and, where applicable, transported under the required conditions; (c) the consignment has remained secure and there is no evidence of tampering during storage or transportation; (d) the identification of the product has been established; (e) the samples tested are representative of all finished product batches derived from the batch of bulk product. 6. Where the qualified person certifies a batch of a veterinary medicinal product in accordance with paragraph 1, he or she shall assign the release status to that batch by means of a formal and unambiguous notification to the manufacturing site releasing the product. 7. Pending the assignment of the release status referred to in paragraph 6, the batch shall remain at the manufacturing site or be shipped under quarantine to another manufacturing site authorised for that purpose. Safeguards to ensure that uncertified batches are not released shall be put in place. Those safeguards may be physical (by using segregation and labelling) or electronic (by using validated computerised systems). When uncertified batches are moved from one authorised manufacturing site to another, the safeguards to prevent premature release shall remain.