Qualified person
Article 38
1. Each manufacturing site of veterinary medicinal products in the Union shall have at least one qualified person. 2. To comply with the obligation set out under Article 97(6) of Regulation (EU) 2019/6, the qualified person shall, as a minimum, verify the following aspects: (a) the source and specifications for the materials used in the manufacture of veterinary medicinal products and the packaging materials comply with the terms of the marketing authorisation; (b) the active substances have been manufactured in accordance with good manufacturing practices and distributed in accordance with good distribution practice; (c) where applicable, the viral and microbial safety and TSE (transmissible spongiform encephalopathies) status of all materials used the manufacture is compliant with the terms of the marketing authorisation; (d) all manufacturing steps, including controls and testing, have been done in accordance with the marketing authorisation and at a manufacturing site authorised therein and in compliance with good manufacturing practice; (e) all required in-process controls and checks, including environmental monitoring, have been made and appropriate records exists; (f) finished product quality control test data shows compliance with the relevant specifications or, where applicable, the real time release testing programme; (g) on-going stability data continues to support certification; (h) the impact of any deviation to the manufacturing process or testing has been evaluated and any additional checks and tests are complete; (i) the impact of any change to the manufacturing process or testing has been evaluated and any additional checks and tests have been completed; (j) audits of manufacturing sites and sites involved in the manufacture or testing of the active substances support the certification of the batch; (k) measures related to the implementation of outsourced manufacture or testing, as provided for in the subcontracting arrangements, are in place; (l) all investigations on matters that may impact the quality of the batch being certified have been completed to a sufficient degree to support the certification of the batch; (m) the self-inspection programme is active. The qualified person, while being responsible for ensuring that the verifications set out in the first subparagraph are done, may delegate those tasks to appropriately trained personnel or third parties. 3. The qualified person shall have access to any documentation relevant to the steps for which he or she assumes responsibility, including details of the marketing authorisation necessary to assess if the relevant requirements have been complied with and relevant data about the entire manufacturing process of the veterinary medicinal product, including importation activities, if any. 4. Where more than one qualified person is involved in the assessment of one batch of a veterinary medicinal product, the division of responsibilities amongst them, including details on the responsibility for assessment of any deviations, shall be clearly laid down in writing. 5. The qualified person may rely on audits conducted by third parties attesting the compliance with good manufacturing practice in specific manufacturing sites. In such cases, the requirements in Article 43 shall apply. The qualified person shall have access to any documentation that is relevant to the review of the audit outcome. For the approval of the audit report, the qualified person shall take into consideration the following: (a) whether the audit report addresses general requirements of good manufacturing practice, such as the quality management system and production and quality control procedures related to the supplied product, with sufficient level of detail so as to allow a conclusion that the relevant activities covered by the audit comply with the marketing authorisation and good manufacturing practice; (b) in the case of outsourced activities, whether there has been verification of the compliance with the marketing authorisation and good manufacturing practice.