Our adherence to current Good Manufacturing Practices (cGMP) provide customers with the assurance that our production procedures meet stringent quality requirements.
What is this?
cGMP refers to the Current Good Manufacturing Practices required to meet product quality standards set by the US Food and Drug Administration (FDA). GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. 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 necessary quality standards.
Why is it important?
Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products 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.