The FDA, or Food and Drug Administration, imposes requirements on companies that manufacture drugs, medical devices, blood products, and food. The list of requirements varies for each industry and is buried within pages of regulations. The FDA is responsible for protecting the public health by ensuring manufacturers are adhering to GMP (Good Manufacturing Practices) principles. GMP principles, in short, are methods in the manufacturing process that maintains the quality of a product.
The purpose of enforcing good manufacturing practices on drug and device companies working in regulated environments boils down to a few reasons – the FDA wants to assure that finished drug products maintain the standard of safety, identity, strength, quality, and purity (SISPQ) that the products were originally meant to have. As part of maintaining the SISPQ, manufacturers must ensure their environments in which the products are manufactured, stored, and transported are adequate for the product. These products can include drugs substances, biologics, and or drug/device combo
products.
Guidance Resources
When viewing the Code of Federal Regulations set forth by the FDA or other regulatory body regulations, one may notice that it often foregoes details or specific requirements as to what type of evidence to provide for environmental monitoring. The FDA is, in essence, requiring that you keep spaces environmentally controlled if your products require specific conditions for production and storage. So where does one begin when determining what type of evidence is needed to demonstrate that an environment is controlled?
There are organizations that provide detailed guidance on these topics and to help you understand specifically what evidence is needed to show auditors that your environment is under control and answers questions such as, “What type of documentation do I need?” or “Do I have adequate monitoring?”. Organizations that have been widely accepted as a standard for reference are
WHO (World Health Organization), ISPE, and USP.
Rationale for Understanding Facility and Placement of Permanent Monitoring
Thermal mapping is often viewed as a requirement to conduct business in a regulated industry. While this is true, people often overlook the value that it adds in understanding the environment they work in every day. A thermal mapping study is exactly what it is named –a study that helps owners identify hot and cold areas within their facility. This provides rational for permanent monitoring areas and assists in pinpointing potential problem areas that may lead to quality issues. For example: analyzing data from a warehouse thermal mapping study can show that one section of the warehouse is too hot or the entire warehouse has risen in temperature over a period in time. An engineer interpreting this data is able to theorize that the HVAC system may not be operating correctly or receiving routine maintenance. The engineer then investigates and determines that the HVAC system was not operating as efficiently as possible and identifies a cost-saving
opportunity.
The result of performing a thermal mapping study is completely dependent on how far the user will want to take it. It can simply be used as proof of regulatory compliance (e.g rationale for permanent monitoring locations) or a very useful tool that engineers can utilize as a resource when solving any issues that may stem from environmental exposure.
Providing Documented Evidence of Compliance
Facilities that process drugs or medical devices often possess millions of dollars’ worth of assets at any given time. Even a minor event such as a power outage or a fire can compromise the integrity of a stable environment. This can have a disastrous effect on a company’s inventory. If a warehouse’s HVAC system experienced a loss of power for an hour, how would a company prove that the product remained within specification? Drastic temperature changes cannot be ruled out as a possibility if there is no evidence of how the warehouse behaves. Providing documented evidence of a facility’s holding, production, packaging, or storage area’s environmental conditions can safeguard material from being ruled as adulterated.
The easiest way to obtain evidence for a facility’s environmental conditions is to monitor areas constantly for temperature and relative humidity. When a loss event occurs, recorded values from the monitoring system can be obtained and reviewed by a quality department. This documented evidence can be presented to a regulatory inspector or to an owner that is auditing a contract facility. If a company demonstrates that its operations are in order and the paperwork is in order, usually audits go smoothly. It’s completely possible that senior management uses the freshly built rapport to show initiative in improving their day-to-day operations. This initiative can produce results that streamline audits in the future. The final result is that companies are able to dedicate fewer resources to addressing compliance issues and more attention towards their customers.
