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Good Manufacturing Practices
In order to ensure the safety and efficacy of pharmaceutical products, the FDA mandates that manufacturers follow a set of methodologies and procedures known as Good Manufacturing Practices, or GMP. These guidelines are the FDA's way of regulating production processes that are constantly changing as new technology enters the scene.
Although specific regulations governing pharmaceutical production are often not feasible when dealing with novel technologies, GMP guidelines establish best practices as they evolve and also provide for extensive record keeping that helps reviewers determine the best way to make a drug. Manufacturers turn to GMP guidelines for direction on how best to perform laboratory processes such as calibrating instruments, preventing contamination, verifying drug stability, and labeling pharmaceutical products.
The FDA has defined current GMPs in 21 CFR 210 and 211. These mandates require drugs to meet quality, potency, and purity standards. In addition to delineating the required characteristics of drugs, GMPs also mandate specialized training and lab environmental controls such as instructions for ensuring freedom from vermin, instructions for how to build and maintain clean rooms, directives on how to house and handle lab animals, and strict policies for compliance.
In addition to the information provided on these pages, we also invite you to visit our Life Sciences Resource Library for complimentary document downloads on a range of topics in Life Sciences that may be valuable to you and your organization.
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