A central aspect of doing business in highly regulated industries, like pharmaceutical manufacturing and distribution, healthcare, or aerospace, is the need to have extensive systems in place to protect consumers and maintain regulatory compliance. That includes systems to monitor the environmental conditions where sensitive products are made, stored, and distributed. 

Luckily, sophisticated and highly automated environmental monitoring tools that are designed specifically for compliance in these industries are available, which can take a great deal of the detailed compliance work off of companies doing business in this space. In this article, we’ll talk more about how environmental monitoring fits into an overall compliance plan, and where these advanced monitoring tools can be used. 

What is environmental monitoring, and why do businesses and hospitals need it?

In the context of pharmaceutical operations, environmental monitoring is a fairly diverse topic. This is largely due to the sensitivity of pharmaceuticals to a variety of environmental conditions, and the potential consequences to consumer health and safety from contaminated or degraded products. 

Another type of environmental monitoring- which we’ll be focusing on in this article- is the collection of temperature, humidity, and pressure of an environment over time. This is done to ensure that sensitive products are maintained within ‘safe’ windows to prevent degradation or contamination. 

Here are a few examples of environmental parameters that are commonly monitored:

• The temperature of refrigerated warehouse spaces, including how temperature varies over location and time
• Chamber temperature of an oven or reactor in a biopharma production line
• Humidity in areas where powdered raw materials are handled, or where a static electrical discharge would be particularly hazardous
• Refrigerators and freezers where vaccines are stored in a pharmacy 
• The differential pressure of a clean room, which is used to prevent microbes or other particles from entering 

There are many of these types of spaces in modern pharma operations, some of which require multiple temperature monitoring points. For this reason, digital data loggers can be a powerful tool, since they automate the process of environmental monitoring, data archiving, tracking sensor calibration status, and other important functions critical for pharma compliance. 

Modern, cloud-based monitoring systems also provide the capability to access data from anywhere. 

When operations are going smoothly, these monitoring systems run in the background, generating a complete record of correct environmental control. If there’s an issue, like a temperature excursion, they can send targeted alerts via phone or email, while collecting a full record of the excursion.  

The reasons for businesses to invest in environmental monitoring can be broken down into three interrelated categories: 

1. Consumer health and safety, as an integral part of maintaining the quality of pharmaceuticals. 
2. Financial protection, as a strategy to maximize yield, minimize scrap, and proactively identify and prevent issues that could lead to product degradation and waste. 
3. Regulatory compliance, since environmental monitoring is part of complying with FDA regulations and GxP-based quality management systems. 

Regarding the last item on this list, the right monitoring system can be an integral part of a compliance program, meeting all of your regulatory requirements while minimizing the burden for onsite staff. We’ll spend the next two sections discussing this in more detail. 

What is compliance in the context of the pharmaceutical industry?

In the US, the requirements for pharma compliance, including in the area of environmental monitoring, are listed in parts of 21 CFR 11, 203, 205, and 211, and are enforced through the FDA. Analogous laws cover other parts of the world, through national or international enforcement bodies like the European Medicines Agency. These regulations, however, provide only a basic framework for compliance. Organizations like the International Society for Pharmaceutical Engineering, U.S. Pharmacopeia, the World Health Organization, and the FDA itself expand significantly on these laws and how they should be applied. 

Having a clear understanding of the laws and guidance that apply to your industry, and incorporating them in a comprehensive quality management system, is key to maintaining regulatory compliance. 

Environmental monitoring systems can contribute to pharma compliance in a number of ways. First, provided that adequate planning steps are taken, and that the right monitoring system is selected and implemented, environmental monitoring per FDA requirements can largely be automated, minimizing the risk of falling out of compliance while reducing the burden on onsite staff. 

Maintaining a clear audit trail through comprehensive record-keeping is also essential for pharma compliance. In their guidance on the topic, the FDA recommends using the ‘ALCOA’ rule for data collection: attributable, legible, contemporaneously recorded, an original copy, and accurate. Automated environmental monitoring systems can be implemented to meet all of those requirements. 

This is true even for a complex, geographically distributed operation with many monitoring points. In these situations, networks of data loggers can be integrated through a cloud-based software tool, where it can be reviewed and archived using methods designed with regulatory compliance in mind. 

Beyond baseline legal compliance, pharma companies may also choose to comply with requirements of various certification or accreditation programs such as ISO 9001 or the Drug Distributor Accreditation (DDA) program. Thorough planning, record keeping, etc including temperature monitoring systems are incorporated into these systems. 

What is the compliance process?

We can think about the pharma compliance process as having three main phases, all of which are subject to review during an audit. The first is planning, in which the organization aligns internally on goals of the overall quality management policy (including environmental monitoring), selects personnel to be responsible for monitoring and compliance, and selects the equipment that will be used. This last aspect is critically important since a vendor with experience in highly regulated industries can be a valuable partner in this step. 

The second phase is validation of the monitoring system. Validation is a requirement for pharma compliance and is a fairly complex process that we’ve discussed in more detail in previous articles. In the context of monitoring, validation involves confirming that the monitoring system is designed for and achieves its intended purpose. For example, for a temperature monitoring system, this could involve temperature mapping a space to determine optimal sensor placement, followed by additional qualification of the sensors themselves. 

Once operations begin, ongoing maintenance, review, and continuous improvement of the system is the third phase. This involves tasks such as regularly reviewing data to check for trends, sensor calibration, and periodically confirming that the monitoring system is properly flagging possible problems.

As we mentioned above, compliance is enforced through applications (for new processes) and audit inspections conducted by the FDA. If problems with the monitoring system are found during an inspection, these can result in a Form 483 “Inspectional Observation” being issued, with further escalation as needed. 

Conclusions

Modern pharma compliance requires a comprehensive monitoring program that enables detailed, precise, and thorough record collection. Compliance in the area of environmental monitoring can be greatly simplified by selecting a monitoring system that is designed specifically with regulatory compliance in mind, through automation, cloud data storage, and other advanced features. 

Questions about environmental monitoring compliance? Contact the experts at Dickson.