The manufacture of biological products shall be undertaken in accordance with the basic principles of good manufacturing practices (GMP). The points covered by these guidelines should therefore be considered supplementary to the general requirements set out in “Good manufacturing practices for pharmaceutical products” (1), and relate specifically to the production and control of biological products. In drawing up these guidelines, due consideration was given to the draft “Guidelines for national authorities on quality assurance for biological products”, the final version of which appears as Annex 2 to the forty-second report of the WHO Expert Committee on Biological Standardization (2).
The way in which biological products are produced, controlled and administered makes some particular precautions necessary. Unlike conventional pharmaceutical products, which are normally produced and controlled using reproducible chemical and physical techniques, biological products are manufactured by methods involving biological processes and materials, such as cultivation of cells or extraction of material from living organisms. These processes display inherent variability, so that the range and nature of by-products are variable. For this reason, in the manufacture of biological products full adherence to GMP is necessary for all production steps, beginning with those from which the active ingredients are produced.
Control of biological products nearly always involves biological techniques that have a greater variability than physicochemical determinations. In-process controls take on a great importance in the manufacture of biological products because certain deficiencies may not be revealed by testing the finished product.
The present guidelines do not lay down detailed requirements for specific classes of biological products, and attention is therefore directed to other guidance issued by WHO, and in particular to the Requirements for Biological Substances, which include requirements for vaccines (2, Annex 7).