THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE
Lack of reactivity has to be demonstrated in the final product (see Section C.5. of Chapter 3.1.8. of the OIE Manual ‘Requirements for registration of vaccine’). In cases where consistency of purification is demonstrated and approved in the registration dossier, and the production process is approved for consistency, the National regulatory Authority may agree to omit the test in the final product. A statement to this effect should be included if such an agreement has been made. Confirmation of vaccine purity may be shown by testing sera from animals vaccinated at least twice with the batch for absence of antibodies to NSPs.
2.E.9. Inactivation test The finished product should undergo a test to verify absence of infectious FMD virus. It shall be carried out on the product in the final container unless it has been conducted at a late stage in-process. In the finished product, antigen must be extracted from adjuvant following an appropriate validated method. A sample representing at least 200 doses of vaccine (including all product presentations) must be used for testing for freedom of infectious virus by inoculation of sensitive cell culture monolayers. After elution, antigen may be concentrated for inoculation in cell monolayers. The test for residual live FMD virus may be omitted for batch release provided that: 1. a titration is performed on each harvest prior to inactivation and the titre is not greater than the maximum titre established based on studies of the inactivation kinetics; 2. suitable test sensitivity for residual live virus has been demonstrated; 3. the test for residual live virus is performed with satisfactory results on each harvest.
2.F Batch consistency – Process validation Section 5.1. ‘Manufacturing process’ of Chapter 3.1.8. of the OIE Manual has to be taken into account. In order to ensure that quality of the product is consistent from batch to batch and to demonstrate conformity with specifications, a batch protocol for three consecutive batches outlining all the production steps, specifications and results for all tests performed during the production process and on the finished product shall be provided. Results of quantitative assays must be expressed as a numerical value with the appropriate limits and not as “pass” or “fail”. Final product tests should include testing for purity, safety and potency. In order to support the consistency of the production and if available, the manufacturer may supply the results of any independent testing e.g. from Official Control Laboratory batch release or recognised reference laboratory testing.
12
