Qualification of suppliers and compliance with specifications
Article 28
1. Suppliers of materials used in the manufacture of the veterinary medicinal product shall be approved after verifying the suitability thereof. In the case of critical materials, the qualification of the suppliers shall be required. The level of supervision of the suppliers shall be proportionate to the risks to the quality of the product posed by the individual materials. 2. The quality requirements (specifications) for the materials used in the manufacture of veterinary medicinal products shall be agreed with the supplier and documented. 3. Compliance with the requirements set out in the marketing authorisation shall be verified by means of appropriate testing. The level of supervision and further testing required shall be proportionate to the risks. The testing strategy shall be justified and, as a minimum, an identity check of each batch shall be performed by means of tests performed on samples taken from all the containers. Sampling a proportion of the containers shall only be acceptable when validated procedures based on quality risk management principles are in place to ensure the correct labelling of containers, and potential risks to the quality are addressed, for example through the qualification of the supplier. At appropriate intervals, having regard to the risks, a full analysis of the active substances and other critical materials shall be performed and the results shall be compared with the manufacturer or supplier’s certificate of analysis in order to check the reliability of the latter. The testing may be outsourced. If that testing identifies any discrepancy, an investigation shall be performed and appropriate measures taken. The acceptance of certificates of analysis from the material manufacturer or supplier shall be discontinued until those measures are implemented. 4. Sufficient experience with the relevant supplier or manufacturer of active substances, including assessment of batches previously received and the history of compliance, shall be required before reducing the in-house testing. Any significant change in the manufacturing or testing processes of the active substances shall also be considered as a relevant factor. 5. Audits at the sites of manufacturers and distributors of active substances shall be conducted at appropriate intervals following a risk-based approach to confirm that they comply with good manufacturing practice and good distribution practice and with the specifications provided. Specific consideration shall be given to potential cross-contamination from other materials on site. Deficiencies shall be clearly identified and corrective and preventive actions shall be implemented as appropriate.