Context, approach and status of the pre-qualification procedure

THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE

(x) symptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose; (xi) withdrawal periods (also known as withholding times), even if such periods are zero;

(d) immunological information;

(e) pharmaceutical particulars: (i) major incompatibilities; (ii) shelf life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time; (iii) special precautions for storage; (iv) nature and composition of immediate packaging;

(f) name of the marketing authorisation holder;

(g) marketing authorisation number or numbers;

(h) date of the first marketing authorisation;

(i) date of the last revision of the summary of the product characteristics.

1.C. Labelling and package leaflet

For the final product, provide samples (or reproductions) of labels, boxes and package inserts to be used in English.

1.D. Lot summary protocol

It is expected that a summary of all manufacturing steps, including in-process and finished product test results from each batch of vaccine, is captured and documented in a standard way and this is referred to as a lot/batch summary protocol, which is certified and signed by the responsible person of the manufacturing company. The vaccine manufacturer should provide a template of the lot/batch summary protocol outlining the information they capture routinely on vaccine batches.

THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE

Chapter 2: Analytical Section /Manufacture and Control

Chapter 2.3.4. ‘Minimum requirements for the production and quality control of vaccines’ and Section C ‘The requirements for vaccines’ of Chapter 3.1.8 ‘Foot and Mouth Disease (infection with Foot-and-Mouth disease virus) of the current version of the OIE Manual ’t are applicable. The information concerning production and control of vaccines is given as an example; it is not always necessary to follow these when there are scientifically justifiable reasons for using alternative approaches.

2.A Composition

State the qualitative and quantitative composition of the product (including diluents if applicable): - the active substance(s): the serotype, strain and potency (in PD50/dose or other validated measures of the active substance); - the constituents of the adjuvants; - the constituent(s) of the excipients, whatever their nature or the quantity used, including preservatives, stabilisers, emulsifiers, colouring matter, flavouring, aromatic substances, markers, etc.

Describe the presentations made available, including diluents (if applicable), dose sizes, type of containers, sterilisation of containers/stoppers and descriptions of application devices to be delivered with the vaccine, if applicable. If the device is not delivered together with the immunological veterinary medicinal product, relevant information about the device shall be provided, where necessary for the assessment of the product.

2.B Method of Manufacture

1. Provide a detailed description of the manufacturing process that shall include, but is not restricted to, the following:

- the various stages of manufacture, including production of the antigen from virus master seed lot and master cell bank, purification procedures, formulation, filling, packaging and any storage periods to support the reproducibility of the manufacturing procedure; - the validation of key stages in the production process shall be demonstrated including: a) validation of the inactivation method including information on the inactivation kinetics with sufficient details to confirm the use of two inactivation vessels and whether, based on the inactivation kinetics study, a safety margin is or is not built into the routine time of inactivation during normal commercial production; b) validation of the sterility method (bacterial and fungal) including information on whether direct inoculation or membrane filtration is used and which pathogens are included in the test; c) validation of the mycoplasma test; - listing of all the substances at the appropriate steps where they are used, including those which cannot be recovered in the finished product;