The ABC of GMP

The code by which ethical, successful, and viable manufacturers operate is known as Good Manufacturing Practice or GMP. These wise production guidelines are more than just helpful suggestions, often times GMP is mandated by local and international guidelines and laws.

Failure to adhere to GMP can result in fines, potential shut downs, and a slew of negative publicity. Manufacturing with integrity is the goal of GMP. The importance of operating a plant in full compliance with GMP cannot be underplayed.

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Managing Compliance with Manufactured Goods
Companies which deal with the manufacturing of industrial, chemical, or commercial goods are especially burdened with the responsibility of following GMP. Many regulatory agencies reserve the right to conduct routine, and unannounced, inspections at production sites within their jurisdiction.

The good news is, a manufacturing company which is educated in GMP will be at an advantage when it comes to complying with guidelines. In fact, understanding GMP and a dedication to follow GMP actually serves to benefit a manufacturing plant and create a safe, productive, and honest production environment.

Every step of the production process should be focused on the health and safety of the workforce involved, the safety integrity of a product, and the health, safety, and well being of the customer or client who will ultimately purchase and utilize the finished product. A GMP plan emphasizes quality and safety at every single stage of production.

The Purpose of GMP
GMP safeguards consumers and the public from harmful manufacturing practices or hazardous final products. GMP ensures that a quality product is produced. In addition, it protects workers who are involved in the production process. Ultimately GMP reduces the liability for a manufacturing firm, due to its highly documented “check list” approach.

GMP is protection against manufacturers which would violate basic health and safety considerations during any stage of the production process. GMP integrates the concepts of good communication practices and good documentation practices.

What GMP Isn’t
GMP is not a definitive guide for how a product or compounds should be manufactured. GMP guidelines do not extend into the nature of production, only into the concept of safety and accountability in how they relate to production steps. GMP is a series of considerations to make while developing a manufacturing strategy, not a manufacturing strategy blueprint.

The World of GMP Watchers
The amount of various Good Manufacturing Practice guidelines for the multiple government and international entities which exist can be dizzying for a project manager. Each country has its own set of guidelines, and many of the guidelines intersect with international agency guidelines, as well as entities which give rankings to companies. Such entities include the United States Food and Drug Administration, the World Health Organization, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, and the International Conference on Harmonization.

Cross compliance can prove complicated for a manufacturing company trying to make sense of the various expectations put upon them by these regulators. However, much of the method behind adhering to compliance is related to having steady documentation and accountability in place for the day-to-day operations of a production process.

Good Manufacturing Practice leads to a safer, more transparent, and more productive production process. Getting in compliance with GMP is something every facilities manager and production manager must commit themselves and their workforce to.