GMP (Good Manufacturing Practice)
GMP (Good Manufacturing Practice) is a quality management system developed by the United States Food and Drug Administration (FDA) to ensure the quality of FDA regulated products like drugs (includes OTC), medical devices, food, etc.
The FDA sets forth guidelines to provide requirements that a manufacturer needs to meet to ensure that their products are consistently high in quality, from batch to batch, for their intended use. The main purpose is to prevent any harm from occurring to the end-user. Quality management systems for FDA regulated products like food, drugs, biologics and medical devices are generally known as current good manufacturing practices (cGMP).
The FDA sets standards through the Code of Federal Regulations (CFR) and carefully monitors the manufacturing practices including their methods, facilities, and controls used in manufacturing, processing, and packaging of drug products of these organizations. The FDA reviews these practices with their assessors and their inspectors determine whether the organization and their facility, equipment, and manufacturing processes comply with their regulations.
For example, facilities dealing with N95 Respirators and Surgical Face Mask must implement the medical device Quality Management System based on 21 CFR 820 and facilities dealing with Hand Sanitizers must implement a drug Quality Management system based on 21 CFR 211.
Implementation of GMP is significant in maintaining a competitive advantage for cannabis industry (Cannabis, CBD, and Hemp GMP).