ABSTRACT
The efficacy of a given sterilization process for a specific drug product is evaluated on the basis of a series of protocols and scientific experiments designed to demonstrate that the sterilization process and associated control procedures can reproducibly deliver a sterile product. Sterilization process validation data, however, should be generated by procedures and conditions that are fully representative and descriptive of the procedures and conditions proposed for manufacture of the product in the application. Microbiological master sites or solutions are those sites or solutions in which it is most difficult to kill the biological indicator under sterilization cycles that simulate production conditions. The completed batch record supplied with the chemistry, manufacturing, and controls section of the application should identify the validated processes to be used for sterilization and depyrogenation of any container/closure components.
