Good manufacturing practice (GMP) is a set of rules and regulations that must be adhered to in a manufacturing plant to ensure the quality of the products being manufactured. It’s not a list of instructions as to how the product should be manufactured, but rather general guidelines that must be met during the manufacturing process. Adhering to these practices is essential because it helps maintain the integrity of the products, keeps the customers happy, and helps with branding. Here’s a look at why GMP is important:
Maintains the Health and Safety of the End User
Complying with good manufacturing practice is mandatory within pharmaceutical and medical device manufacturing to ensure the health and safety of the end user. GMP is designed to minimize or eliminate any risks involved in production such as instances of contamination, mix ups, or other errors. Proactive steps outlined by the Good Manufacturing Practice Regulations set forth by the U.S. Food and Drug Administration ensure that products manufactured by processors and packagers of drugs, medical devices, some food, and blood are safe, pure, and effective.
Covers All Aspects of Production
GMP covers all aspects of production, which includes the materials used, the conditions of the premises and equipment, and the training and hygiene of any staff that enter the manufacturing facility. Procedures must be documented for each process to provide evidence that GMP regulations are being adhered to throughout each step in the process every time a product is made. If a drug is found to be manufactured in an environment that violates GMP guidelines it can be deemed adulterated, even if it passes all specification tests. This is to protect the consumer from purchasing a product that is not effective or could be dangerous.
Ensures Regulations Are Being Followed
GMP regulations must be followed by anyone that enters the plant, including visitors or outside vendors or contractors. All actions taken by these individuals must also be logged. Outside vendors and contractors must learn the GMP requirements for the specific manufacturing plant that they will be working in and use only approved work methods. Each plant has different requirements and decides individually how to best implement the necessary controls in a way that makes sense for that business.
GMP may also be referred to as “cGMP” or “Current Good Manufacturing Practice”. This is because regulations are always changing as technology and equipment changes. Equipment that was used ten years ago may no longer be valid. Manufacturers must stay up to date in order to be GMP compliant.
Are you wondering how companies can adhere to good manufacturing practices? Get in touch with Fishman Corporation’s team for more information.
Source: http://www.ispe.org/gmp-resources