Presentation of the EEC directive (81/852)--quality

The EC directive 81/852 has been revised to include a number of parts setting out the information to be included in applications for marketing authorizations for veterinary immunological products. Part 6 contains the details of the quality aspects which must be addressed by the applicant. It is divided into sections and provides the applicant with the structure and layout to be used for the presentation of the information in the dossier. The applicant must provide sufficient detail to allow the competent authority to assess the quality of the product, including aspects such as batch-to-batch consistency and the risk of contamination of batches with extraneous agents. Thus the dossier must contain details of the starting materials, the method of manufacture, and the controls and tests on the starting materials and intermediate and finished products. The details of the blending and composition must be included. Limits of acceptance should be provided. Procedures used such as inactivation and purification steps and quality control tests should have been shown to be appropriate and the results of the validation studies must be presented. The information supplied must be accompanied by results obtained from batches manufactured by the method described. A justification of the proposed shelf-life of the product must be made with supporting evidence from real-time stability studies.