Commission Directive 2009/9/ECShow full title

B. DESCRIPTION OF MANUFACTURING METHOD

The description of the manufacturing method accompanying the application for marketing authorisation pursuant to Article 12(3)(d), shall be drafted in such a way as to give an adequate description of the nature of the operations employed.

For this purpose the description shall include at least:

• the various stages of manufacture (including production of the antigen and purification procedures) so that an assessment can be made of the reproducibility of the manufacturing procedure and of the risks of adverse effects on the finished products, such as microbiological contamination; the validation of key stages in the production process shall be demonstrated and the validation of the production process as a whole shall be demonstrated with provision of results of three consecutive batches produced using the method described,

• in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity and consistency of each batch of the finished product,

• listing of all the substances at the appropriate steps where they are used, including those which cannot be recovered in the course of manufacturing,

• the details of the blending, with the quantitative particulars of all the substances used,

• a statement of the stages of manufacture at which sampling is carried out for control tests during production.