The process of complying with the requirements of good manufacturing practice guidelines is considered by many FDA-regulated companies to be a time consuming and expensive ordeal. In fact, the opposite is true: not complying with GMP guidelines can be a time consuming and expensive ordeal.
The FDA's current good manufacturing practice guidelines are there to ensure that products are consistently produced in a controlled environment with quality standards guiding their intended use. For more than two decades, MasterControl has led the quality management software industry in providing the products, training, and support that companies need to attain and sustain compliance with good manufacturing practice guidelines.
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The FDA devised cGMP, or Current Good Manufacturing Practice regulations, as a means to establish a foundation for drug product quality. These good manufacturing practice guidelines are enforced by the FDA in order to ensure that life science companies are utilizing systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adhering to good manufacturing practice guidelines, as the FDA states in its Facts About Current Good Manufacturing Practices, “assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.” Quality management systems, or QMS, are crucial to maintaining “adequate control” at even the most basic level. The good manufacturing practice guidelines are minimum requirements that are flexible enough to allow manufacturers to make decisions based on their individual organizational needs in regards to the best methods of implementing the necessary controls according to scientifically sound processing methods, testing procedures, and design.
Can you tell just by looking at a pill if it will work or not when you swallow it? Does it smell like it has spoiled? As consumers, we usually can’t detect with our senses whether or not a drug product will work or if it is safe. Good manufacturing practice guidelines exist to help ensure that drug products are safe and that they work as they are supposed to. According to the FDA, drugs must be “manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step.” To make certain that good manufacturing practice guidelines are followed, the FDA enforces cGMP regulations by monitoring manufacturers’ facilities (to check that they are in good condition), equipment (to see that it is properly maintained and calibrated), employees (to make certain that they are qualified and fully trained), and processes (to ensure they are reliable and reproducible).
For more than two decades, MasterControl has provided hundreds of companies around the world with quality management software solutions that help them achieve and maintain compliance with good manufacturing practice guidelines. MasterControl software has been specifically designed to help companies doing business in regulated environments with quality management issues such as:
These are just a few of the quality management processes that MasterControl software solutions are designed to streamline. For a more comprehensive list of MasterControl offerings, visit the Solutions page on the MasterControl website.
For more information about GMP guidelines and to find out how our software can help your company meet current good manufacturing practices, contact a MasterControl representative at 801-942-4000 or visit MasterControl’s Resource Center for free white papers, webinars, and other informative downloads.