What does "environmental monitoring" refer to in a GMP facility?

Environmental monitoring in a GMP facility specifically refers to the assessment of microbial and particulate levels within the manufacturing environment. This process is crucial for ensuring that the production area adheres to the specified standards of cleanliness and sterility, which are pivotal in preventing contamination of pharmaceutical products.

By regularly monitoring environmental conditions, facilities can identify potential issues that could compromise product quality and safety. This can involve taking air, surface, and water samples to evaluate the presence of contaminants that could affect both the manufacturing process and the final product.

This focus on maintaining a controlled environment helps to ensure compliance with regulatory requirements and supports product integrity throughout the manufacturing lifecycle. Thus, option B accurately captures the essence of environmental monitoring in a GMP setting.