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In an effort to ensure the quality of the drugs they produce, many pharmaceutical companies have established strict guidelines and regulations regarding Good Manufacturing Practices (GMP). Unfortunately, despite the best efforts of these companies, there are still times when their products fall short of GMP standards In this article, we’ll look at some common GMP violations and how they can affect your business.
What is a violation of Good Manufacturing Practice?
GMP stands for Good Manufacturing Practice and is a set of rules that must be followed while manufacturing pharmaceuticals. There are several different types of GMP violations, but the most common are deviations from good manufacturing practices related to manufacturing processes, controls, and records. Violations of this can have serious consequences for every manufacturer, so it is important to ensure that all procedures are followed correctly.
How common are GMP violations?
GMP violations in the pharmaceutical industry are not a new phenomenon, but they have increased recently. In fact, according to a recent report by the Food and Drug Administration (FDA), GMP violations have increased by 54% in recent years. What is behind this growth?
One possible explanation is that drug companies are becoming more focused on cost reduction. This can lead them to skip safety measures to save money, which can ultimately lead to GMP violations. Additionally, pharmaceutical companies may be less aware of their GMP compliance obligations due to the current economic climate. Finally, there is a tendency for companies trying to enter new markets, which can often lead to lax GMP compliance practices.
Whatever the reason, it is clear that GMP violations are on the rise and pharmaceutical companies need to be taken seriously. If enough are caught, they can be corrected without too much trouble. However, if not corrected, GMP violations can lead to serious safety risks for patients and even product recalls. So it is important for companies to be vigilant when it comes to GMP compliance.
