THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE
- titration of the virus. Information should be provided on the storage of the MSV and WSV (conditions and duration). 2. Cell seed The cell seed should be identified by historical records and include information on origin, species of origin, in vitro passage history, including ingredients used and adaptation, if required. The use of a continuous cell line for the propagation of FMD virus should be based on a cell bank system. Details of propagation conditions for the MCB and WCB should be described. The maximum number of passages allowable between the master cell bank (MCB), the working cell bank (WCB) and the production cells should be defined. The following tests should be performed on the MCB and the WCB: - identification of species; - microscopy; - bacteria, fungi and mycoplasmas; - extraneous agents. The following tests should be performed on the MCB and the cells at maximum production level: - karyotype; - retroviruses; - tumorigenicity. Information should be provided on the storage of the MCB and WCB (conditions and duration).
3. Other materials of biological origin For all other starting materials of biological origin used at any stage in the manufacturing procedure the following information should be provided: - details of the source of the material (origin including geographical region and tissue); - if applicable supplier information and material specification including an example certificate of analysis; - details of any processing, purification and inactivation applied, with data on the validation of these process and controls during production; - details of any tests for contamination carried out on each batch of the substance; - a table summarising the extraneous agents tested for and the tests used (cells or substrates of amplification, methods of detection).
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