Microbiological Contamination Control Principles

The principles of controlling microbiological contamination in pharmaceutical preparations are part of GMPs and are quite simple:

• Identify the sources of microbiological contamination. Where possible eliminate them. If this is not possible, minimize them

• Identify the vectors for transmitting microbiological contamination. Where possible eliminate them. If this is not possible, minimize them

• Identify critical operations and provide local protection around them

• Identify and minimize the opportunities for microorganisms to proliferate

• Monitor the effectiveness of the control measures

The practicality of controlling microbiological contamination in pharmaceutical preparations is more complicated than the theory. Some contamination risks may be generic to all facilities in which particular product types are manufactured. Other risks may be functions of particular manufacturing processes or conditions. Yet others may be functions of the products themselves (e.g., their formulations). The extent to which it is necessary to control these risks differs from one product to another because of differing risks to the patient.

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