Viable Monitoring During the Filling of a Terminally Sterilized Pharmaceutical Product-Risk Based Approach

This article addresses a risk based approach to establish a routine monitoring program of viable (I.e. microorganisms) in a controlled environment used to produce pharmaceutical products that are intended to be terminally sterilized. Current applicable quality system regulation & GMP require appropriate environment to be established, maintained and monitored for the manufacturing of the terminally sterilized pharmaceutical meanwhile the appropriate environmental monitoring plan is not clearly specified & a risk based approach will be a valuable tool to design a suitable program Table 1: Variable Very Low Low Normal High Very High Risk factor (A) Amount of microbial contamination on, or in, a source 1-2 (Class A) 3-4 (Class B) 5-6