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Strategies for Remaining in FDA Compliance


When creating any sort of product manufacturers must operate with constant attention to detail. This is especially the case in the ever-changing and challenging landscape of the regulated world of pharmaceuticals and how it’s constantly shaped by the research of what different drugs and chemicals do to a person’s body, both over time and in different combinations. As a result, compliance with FDA regulations is paramount to staying in business and protecting your patients and your company. In today’s fast-paced environment, a solid compliance strategy is essential to staying on track with the latest requirements by the FDA if you want to manufacture and sell anything having to do with pharmaceuticals.

A solid compliance strategy requires planning, implementation of best practices, and ongoing monitoring of your operational performance. Failure to stay on top of these things can result in fines, warning letters, and even a facility shutdown if the problem is allowed to persist. To make sure you stay in compliance, here are some tips to help you stay in compliance.

Understanding FDA Regulations

Before developing a strategy for remaining in compliance, you must first understand the regulations your business needs to follow. Basically, you need to know what the rules are before you can devise a strategy for how to follow them. Some of these rules include things such as the labeling, packaging, and storage requirements for the pharmaceuticals you sell. It also pertains to how you go about marketing your product, such as making sure the advertisements aren’t misleading and being upfront about potential side effects anyone who takes them could experience. The FDA has a wide range of resources available to help you understand the different regulations, and it’s important that you familiarize yourself with them. 

Although this can seem like an overwhelming task, your need for remaining in compliance and protect the health and safety of your patients should be one of the first goals you have. For each of your business activities, including research, clinical trials, manufacturing, and distribution, corresponding FDA regulations must be followed. For example, the FDA is responsible for ensuring the safety of drugs and medical devices distributed in the U.S. This includes ensuring that new drugs are safe and effective, that medical devices are safe, and that all facilities are properly equipped.

Seek Professional Guidance

As you begin to understand the various regulations that apply to your business, it is important to seek the guidance of professionals with knowledge of the field. It will ensure that you fully understand each regulation and how to implement best practices to ensure you remain in compliance.

When figuring out what you need to do for your company, determine which regulations apply to your product and seek either individual experts or organizations that can guide the best way to comply with the requirements involved. When seeking compliance certification, it’s likely best to go with a third-party organization that is accredited by the FDA. Once you have selected an expert, they can help you develop compliant practices for your business and monitor your progress to ensure that you remain on track. For example, you can seek the services of an FDA compliance consultant. A consultant will know the ins and outs of compliance and will help you determine how you will implement operating procedures to ensure compliance such as risk management and data integrity are achieved.

Develop Operational Excellence Practices

Another thing you can do to remain in compliance is to implement some of the best practices that have been proven to be effective in the past, either by your company or by competing companies also held to the same standards as yours. Once you understand the regulations that apply to your business, it’s best to determine just how you will run procedures that are in compliance. This is known in the industry as developing operational excellence practices. If you’re curious for more information, most companies have standard operating procedures (SOPs) that describe how to run a business.

Select a Quality Management System

Once you have implemented best practices, it’s time to consider what quality management system will be best for your business. Quality management systems are designed to manage your risk and ensure compliance with all applicable regulations.

This will include a risk assessment to identify potential hazards and vulnerabilities you need to account for. After that, you will also develop a plan for identifying and monitoring critical quality characteristics that can impact either your product or patients, or both for that matter. These characteristics will be identified and monitored throughout the entire supply chain so that you have an ongoing idea of what’s going on or what might need to change as time goes on.

Monitor Your Processes and People

Now that you have a quality management system in place, it’s important that you monitor your processes and people to ensure they consistently produce safe products. This includes monitoring the critical quality characteristics essential to the safety and effectiveness of your products and devices.

When proving that you’re adhering to FDA compliance, investigators will review your monitoring records to ensure that you consistently produce safe products and remain on top of watching for defects, problems, or complications. This review will include how you test the pharmaceuticals, where your raw materials come from, and who does the testing along with the results.


In order to ensure FDA compliance, it’s important to have a clear understanding of the regulations that apply to your business. You should also seek out the guidance of experts in the field to make sure you’re prepared for even the more nuanced aspects of compliance. Once you have a clear understanding of the regulations, you can develop operational excellence practices and put a quality management system in place to help you monitor your progress and ensure compliance. And finally, it’s important to monitor your processes and people on an ongoing basis to make sure that you consistently produce safe products. By following these steps, you can be confident that you’re doing everything possible to remain compliant with FDA regulations.


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