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A central aspect of doing business in highly regulated industries, such as pharmaceutical manufacturing and distribution, healthcare, and clinical trial, is the need to have robust systems in place to protect consumers and maintain documented regulatory compliance with Good Manufacturing Practices (GMP). This includes systems to monitor the environmental conditions where sensitive products are manufactured, stored, and distributed.?

Luckily, sophisticated and highly automated environmental monitoring tools that are designed specifically for compliance in these industries are available. These tools can eliminate much of the tedious compliance work for companies and allow them to focus more energy on their core business.?

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.?

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Monitoring in the health industry can take many different forms, as pharmaceutical products and manufacturing processes are highly diverse and sensitive to different types of physical parameters, such as temperature, humidity, CO2 levels, and even differential pressure.

The focus is to make sure certain physical parameters are within a target window of optimal values in order to consistently maintain pharmaceutical products under optimal conditions and protect them from degrading. Health products can be sensitive to temperature in labs, warehouses, production facilities, and during transportation. The same applies to products relying on ovens and reactors in the biotechnology industry.

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External conditions such as relative humidity or temperature that is too high or too low can degrade products, which is why it is so important to track physical parameters.

• Monitoring can have a positive impact on people’s health by helping to maintain medicine quality across the entire cold chain.
• Monitoring protects financial investment by helping maximize yield, minimize scraps, and proactively identify and prevent issues that could lead to material degradation and waste.
• Monitoring supports companies’ regulatory compliance efforts, as pharmaceutical manufacturing, storage, and use are subject to very strict quality management regulations imposed by the European Medicines Agency (EMA), Food and Drug Administration (FDA), French National Agency for Drug and Health Product Safety (ANSM), and others.?

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Quality control and compliance systems worldwide are essentially intended to help preserve people’s health. They represent a framework to assess the quality and reliability of manufactured medical products and devices, according to the activity sector.

With appropriate parameters, settings, and the right environmental parameter monitoring system, many requirements for meeting regulatory agency expectations can be automated. This minimizes the risk of non-compliance for companies while lightening the workload for staff.?

Automated always-on systems are key for being prepared for audits regarding pharmaceutical production compliance. The FDA also recommends using the ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) method to collect and store monitored data. This also holds true for regulatory compliant solutions in complex worldwide organizations, where data logger information and reports can be Cloud-based.

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With respect to monitoring, compliance can be defined in three key steps:?

• The first step is to plan carefully. It is essential to conduct a complete review of both production and Quality agency expectations, notably by involving the people in charge of compliance and regulatory affairs. Choosing the right supplier for highly regulated environments is a critical part of this step, as they can offer invaluable support for implementing an adapted solution.
• The next step is to validate the chosen monitoring system. This involves confirming that the monitoring system supports target operational metrics at all levels, from performance to robustness to security. For temperature monitoring, for example, validation can include mapping monitored zones to identify the most effective locations for sensors, data loggers, gateways, and servers (Cloud-based or on-premises). All equipment is then qualified extensively through documented and traceable installation and operational Qualification documents.
• Lastly, a durable system requires ongoing improvement, complete with maintenance and system updates. This includes examining your equipment on a regular basis to ensure accurate sensor calibration, as well as testing the alarm system to make sure the right people are notified quickly in case of excursions.

When it comes to compliance audits, a properly implemented monitoring system can help avoid discovering unexpected dysfunctions that could lead to non-conformity that impacts your business.

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Modern pharmaceutical compliance with GMP requires a comprehensive monitoring program that enables detailed, precise, and thorough record collection. Compliance regarding 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, reporting, and other advanced features.