The concept of Good Manufacturing Practice (GMP) quality is evident everywhere: in food and drinks that we consume, in buildings and structures, cars and airplanes, general manufacturing, and in drugs, medical devices, and hospitals and laboratories. In the U.S., the Pure Food and Drug Act in 1906 made it illegal—for the first time—to sell adulterated food and drugs. It was the beginning of the concept of GMP quality, which refers to practices that help ensure product quality and consumer safety.
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The U.S. Food and Drug Administration (FDA) enforces regulations for pharmaceutical, medical device, blood and biologics, food, and other regulated industries. Those regulations embody Good Manufacturing Practice quality principles. The FDA also provides guidances that reflect GMP quality standards and offer a framework for compliance.
Of all the GMP quality-related regulations enforced by the FDA, perhaps these two are the most important and have the most impact:
A wide range of manufacturers throughout the world voluntarily adhere to ISO 9000, a series of GMP quality standards, because most companies prefer suppliers and providers with ISO certification. ISO 9000 applies to most manufacturers but there are other ISO standards specially developed for certain industries.
For example, ISO 13485 and ISO 14971 are the most widely recognized GMP quality standards for producing medical devices. These standards are voluntary, but regulatory bodies throughout the world encourage and expect medical device manufacturers to follow them to ensure Good Manufacturing Practice quality in all aspects of their operations.
ISO 13485 focuses on the creation and maintenance of a quality management system, while ISO 14971 provides risk management guidelines that apply specifically to medical devices. Together these standards help manufacturers implement processes that comply with regulations pertaining to Good Manufacturing Practice quality.
MasterControl quality and compliance software helps companies throughout the world in complying with GMP quality regulations and standards. It is an end-to-end solution that automates and connects all quality processes for a holistic approach to regulatory compliance.
Here is how MasterControl helps companies attain and maintain compliance with GMP quality regulations.
For more information about quality and compliance, and how our software can help your company meet current good manufacturing practices, please feel free to contact a MasterControl representative.