Process Capability Requirements

Abstract “Process capability” is the process’s ability to deliver product of the required quality in the quantity necessary for each step in the life cycle of the product. In order to be of any practical value, a process intended to make biopharmaceuticals needs to meet the standards set by local and regional regulatory authorities around the world. It needs to reproducibly and economically manufacture the specified quality of the drug or vaccine it is designed for. This aspect involves the removal of any risks to the patients that may originate with the product. In addition to processes themselves, the ability to cope with the production of an ever-increasing number of drug candidates in the same facility is an additional focus. Appropriate operational flexibility in coping with different process requirements is an element of company production strategy that helps to save time and effort. A basic requirement with essentially every process nowadays can be described as "reduced development time and effort." Process developers must aim for process designs that cover most (preferably all) of the molecules of the same category entering development. Such designs form what is commonly referred to as platform processes.