It is important that vaccines should be manufactured in accordance with a recognised codified system that includes specifications regarding equipment, premises, qualification of personnel as well as quality assurance and regular inspections. A commonly agreed system of facility inspection carried out by qualified and specialised inspectors must be in place to assure confidence. Information to be submitted when applying for registration in the importing country The manufacturer or Veterinary Administration of the exporting country should make available to the importing country the pharmacopoeia it uses. For the importing country it is necessary to have documented both the quality control methods used and the source of each batch of starting materials. The key steps of the manufacturing process of veterinary vaccines should be described in detail to help risk analysis.
Risk analysis has to be focused on the quality and safety parts of the application file.
Laboratory safety testing should cover target and non-target organisms to obtain sufficient biological data. All test procedures used should correspond with the state of scientific knowledge at the time and should be validated. The description of the method of preparation of the finished product should include an adequate characterisation of the substances needed to prepare the working seeds, the description of the treatments applied to starting materials to prevent contamination, and a statement of the stages of manufacture at which sampling is carried out for process control tests. The results of control tests during production and on finished product, as well as the sensitivity of these tests, have to be available for risk analysis. The stepwise procedures of the control tests should also be available.