Production

Production
Statements given under the heading Production draw attention to particular aspects of the manufacturing process but are not necessarily comprehensive. They constitute mandatory instructions to manufacturers. They may relate, for example, to source materials, to the manufacturing process itself and its validation and control, to in-process testing or to testing that is to be carried out by the manufacturer on the final product (bulk material or dosage form) either on selected batches or on each batch prior to release. These statements cannot necessarily be verified on a sample of the final product by an independent analyst. The competent authority may establish that the instructions have been followed, for example, by examination of data received from the manufacturer, by inspection or by testing appropriate samples.
The absence of a section on Production does not imply that attention to features such as those referred to above is not required. A substance, preparation or article described in a monograph of the Pharmacopoeia is to be manufactured in accordance with the principles of good manufacturing practice and in accordance with relevant international agreements and supranational and national regulations governing medicinal products.
Where in the section under the heading Production a monograph on a vaccine defines the characteristics of the vaccine strain to be used, any test methods given for confirming these characteristics are provided as examples of suitable methods. The use of these methods is not mandatory.
Additional statements concerning the production of formulated preparations are given in the general notice on Manufacture of Formulated Preparations.