ABSTRACT
Pharmaceutical products are subject to microbiological contamination that can represent a health hazard to the consumer and cause product spoilage, aesthetic changes, and possible loss of drug efcacy. Microbial contamination may originate from the raw materials and excipients or may be introduced during manufacture (operators and contaminated equipment, environment, and packaging materials), storage, and use. Most raw materials used in pharmaceutical manufacturing, including water, may contain several types of microorganisms. Depending on the type of the manufacturing process, these contaminants may be reduced or eliminated. However, care must be taken not to further increase the potential for introducing microorganisms during an uncontrolled manufacturing process.
