Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is a set of guidelines and regulations set forth by regulatory agencies such as the FDA (Food and Drug Administration) and WHO (World Health Organization) to ensure that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing. 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.

GMP covers all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. The main risks of not following GMP are unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

GMP regulations are mandated by manufacturers’ respective national governments to regulate the production, verification, and validation of manufactured products and ensure that they are effective and safe for market distribution. GMP standards are developed to enhance the safety of manufactured products, especially pharmaceutical goods, and to ensure consumers get the highest quality possible. Adherence to GMP standards not only positively impacts the reputation of manufacturing companies but also reduces batch recalls and negative reports from consumers.