ABSTRACT
All involved in pharmaceutical and medical device manufacture will realize the versatility and robustness of microbes and their ability to cause havoc in products, processes and premises without warning. The skilled auditor can, however, make a preemptive strike! By identifying potential contamination sources, and by recognizing the vulnerability of product and process, the auditor is well placed to minimize-if not prevent-poor microbiological control. In order to be effective, the auditor requires some essential skills and a good understanding of: microbial ecology and the essential characteristics of micro-organisms; the production process and environment; the product, its characteristics and use; and how to conduct audits in a timely and efficient manner.
