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Drug manufacturing facilities are required to establish facility and process controls to prevent microbiological contamination (21 CFR 211.113). Bacterial endospores and fungal spores present significant contamination challenges in drug production areas due to their prevalence in the environment and inherent resistance to chemical inactivation. Spore forms of both organisms develop, in part, due to adverse environmental conditions, producing a dormancy that allows the core genetic material to survive until conditions for growth are present. While a bacterial endospore, such as Bacillus cereus, demonstrates greater resistance, fungal spores, such as Aspergillus niger, typically demonstrate more resistance to chemical inactivation than other vegetative microorganisms.

Many recent 483 observations and Warning Letters demonstrate deficiencies in addressing spore control. Control of bacterial and fungal spores requires a holistic approach to managing the environment. This approach should include examination of the contributory factors related to introduction of bacterial and fungal spores to the facility and to effective remediation, including facility design, personnel compliance, and cleaning practices.