Microbiological Control Strategy

The effectiveness on the controls can be continuously evaluated with sound microbiological monitoring and trending of results. This chapter presents high-level multiple microbial controls that can be introduced during production of non-sterile drug products. A comprehensive microbial control program should allow to identify the risk of contamination to the product as well as the different mitigation steps to control this risk. The systems used to control the environment of the facility are qualified prior to running operations and are part of the facilities' life cycle. Product ingredients may be a significant source of microbial contamination risk especially if they are of natural origin. The utility that represents the most risk to microbial contamination is the process water used as solvent in the non-sterile product formulations or for cleaning of equipment product contacting surfaces. The equipment cleaning prevents product cross-contamination for non-dedicated equipment and reduces the number of microorganisms to an acceptable level.