ABSTRACT
Since 1990, many important initiatives have been undertaken within the International Conference on Harmonization (ICH) between industry associations and regulatory authorities to promote harmonization of technical requirements for product registration between Japan, the United States and the European Union. The ICH Steering Committee, since 1991, has been advised by Expert Working Groups on quality, safety, and efficacy. In general, biological products also show a higher degree of batch-to-batch variability, a fact that should be taken into due consideration while planning and performing stability studies. The document mentions a number of products that are generally considered as being biotechnological and biological products but are covered by it, namely antibiotics, heparins, vitamins, allergenic extracts, whole blood, or cellular blood components. Potency testing should be part of the stability studies wherever the Intended use of a product is linked to a definable and measurable biological activity.
