The Consequences of GMP Non-Compliance

Updated on August 28, 2023
The Consequences of GMP Non-Compliance

Compliance with Good Manufacturing Practices is crucial to manufacturers. Good Manufacturing Practices (GMP) follow many guidelines for the key elements of manufacturing to ensure the production of products and the products themselves are of the highest quality and safe for consumer use. One should always follow GMP guidelines, but what happens if a manufacturer does not follow GMP? The consequences of GMP non-compliance can have serious effects on your business.   

Damaged Reputation  

The first impact your business will face if choosing to not comply with GMP standards is a damaged reputation. A strong reputation brings in customers and keeps existing customers loyal to you. When dealing with the manufacturing of already dangerous products, such as pharmaceuticals, customers want to know you are being cautious. If customers do not trust your processes, they won’t risk purchasing and consuming your products, leaving you with a damaged reputation. When a consumer loses trust in your business because you don’t comply with GMP, they may wonder how many others in the industry are not complying. Eventually, this could hurt the entire industry.   

Increased Product Recalls  

Not following GMP puts your business at risk of creating unsafe products. This increases your chances of having to recall product batches. Product recalls tell the public that you produced a product that is a danger to their health, damaging your reputation further. Additionally, a recall based on GMP non-compliance usually does not only impact one product. If you are producing one product with non-compliance, all your products have likely been produced the same way, resulting in a manufacturer wide recall. Recalls continue to disrupt your business’s reputation and waste time, money, and resources.   

Criminal Prosecution and Fraud Accusations  

When GMP is not followed, the risk of a consumer becoming seriously ill increases. Criminal prosecution or accusations of fraud are then more likely if you fail to label your products in compliance with GMP and consumers fall ill. The repercussions of criminal prosecution and fraud accusations can lead to a severe and costly situation to get out of.   

License Cancellations  

Licensing is an important part of working in manufacturing. Failing to comply with GMP puts your business, facility, and physicians at risk of losing their license. Loosing licensing can largely discredit your business and make it hard for you to recover.   

The consequences of GMP non-compliance should not be overlooked. A loss of a solid reputation, legal complications, and license cancellations are all serious enough to put you out of business.