ABSTRACT
A fundamental prerequisite for the manufacture of quality sterile products, as with other pharmaceutical products, is the research and development of products that are demonstrably efficacious and acceptably safe. The additional requirement for a sterile product is that a suitable, fit for purpose, sterilization process has been established and validated as part of the product development phase. There is no point whatsoever in developing a product that can be shown to be splendidly efficacious and safe from an “ordinary” pharmacological or toxicological aspect, but which, if intended for injection, cannot be reliably sterilized when manufactured on a commercial scale.
