Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use. These risks include contamination which could cause damage to customers health, incorrect labels on products which could lead to customers receiving the wrong medicine, and varying dosages of active ingredients leading to ineffective treatments or adverse effects (World Health Organization, 2015).
The FDA takes ensuring that all Standard Operating Procedures (SOPs) are GMP very seriously as it has the ability to impact public health in an adverse way if they are not followed. Having adequate, documented SOPs for production and process control can help ensure that products are produced consistently and with properties they are intended to have. Other GMP requirements include validated cleaning procedures between batches so that operators can effectively and consistently clean equipment in between lots, adequate material system design and controls which allow organizations to effectively design, control, maintain, and monitor systems for materials used within the process, and an effective validation program which evaluates the soundness of design and state of control of a process throughout its lifecycle to ensure products are produced in the manner which they are represented (Division of Pharmaceutical Quality Operations II, 2023).
The quality team of an organization provides oversight and manages these processes to ensure that pharmaceutical drugs, or any products are produced in a manner that is safe for public use. If you need support in understanding or implementing GMP systems to improve product quality, the experts at EMMA International can help! Call us at 248-987-4497 or email us at info@emmainternational.com to learn more.
