Environmental monitoring in the pharmaceutical industry is a critical requirement of good manufacturing practices – GMP. It is used to make sure that Pharma product manufacturing is carried out in controlled environmental parameters. It also ensures that surrounding environment does not cause any harm or damage to the Pharma product during its entire production life cycle.
Environment monitoring includes detecting deviations in environmental parameters from standard values. This is achieved by analyzing the historical record of a particular area.
Keeping and analyzing historical data also enables for performance assessment, root cause analysis and implementing Corrective Action and Preventive Action - CAPA.
Importance of environmental monitoring
Let's discuss the importance of environmental monitoring in pharma industry, and see why Pharma manufacturers worldwide invest in this field.
Regulatory requirement
Environmental monitoring is a critical requirement by regulated bodies worldwide for manufacturing Pharma products. Almost every regulatory body, critically reviews and asses the environmental monitoring practices and provide feedback if an improvement is required.
Regulatory bodies also inspect to see whether equipment and instruments for environmental monitoring are according to the highest standards of Pharma manufacturing requirement and regulatory guidelines.
If a regulatory body is satisfied with the environmental monitoring practices, equipment, and policies, it accreditations its manufacturing status. Otherwise, regulatory bodies can issue a warning or even shut down plant operations.
Helps in product safety
When implemented, properly, with appropriate equipment, practices, and guidelines, environmental monitoring helps product safety in Pharma manufacturing. This becomes necessary for aseptic product processing, where the product’s impact is higher than any other form.
Environmental monitoring also helps to detect, if a product is contaminated. In this case, the product can be immediately held back from release to save human life and, subsequently, protect the pharma organization from legal actions.
Indicate the status of processing equipment.
Environmental monitoring gives first hand status of the equipment responsible for maintaining the environment. Because there are several equipment and components involved in maintaining the environment, such as air handling units, filter systems, diffusers, and grills.
Although, during system design, special care is taken to prevent the accumulation of foreign bodies and tp prevent a possible source of contamination, chances are that during production, these components can cause problems for many reasons.
Environmental monitoring helps to determine what equipment has become a problematic or started to degrade. It also helps to solve these problems in advance, prevent breakdown in production operations.
Types of environmental monitoring
In the pharmaceutical industry, every physical entity that remains near a pharma product or manufacturing process is checked for monitoring. Let's look at common objects frequently monitored as a part of environmental monitoring program.
Air monitoring
Air is a common medium for Cross contamination in a pharma manufacturing operation. If air quality is compromised, it becomes difficult to protect existing products or manufacturing processes.
Air Monitoring includes sampling and analyzing the air quality for microbial contamination. Some areas of a pharma operation where it is used are manufacturing areas, change rooms, and cleanrooms.
Commonly, there are two types of air monitoring in the pharma industry - active and passive.
Active air mo...
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