Facts About the Current Good Manufacturing Practices (CGMPs) from the US Food and Drug Administration (FDA)
Neuroline Solutions formulas are all manufactured in a cGMP Certified facility. This is important to note when you purchase our carefully researched natural formulas, as the US FDA carefully monitors pharmaceutical facilities for quality and safety.
The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how the FDA assures that drug manufacturing processes meet these basic objectives.
What are CGMPs?
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products and supplements like Neuroline Solutions formulas by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards - which is critical to the Neuroline Solutions mission of providing safe, effective products to help the people who trust us enough to purchase our products.
Why are CGMPs so important?
CGMPs are vital as consumers usually cannot detect (through smell, touch, or sight) that a drug product is safe, or if it will work. While CGMPs require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are 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. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.
Want to know more about CGMPs?
For complete information about cGMPs, visit the Food and Drug Administration’s website: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm