WHAT IS GMP?

GMP stands for “Good Manufacturing Practices.” GMP is a set of guidelines that creates a consistent and systematic approach for ensuring the quality of products, including dietary supplements and pharmaceutical products. GMP considers different elements of the manufacturing process and outlines expected procedures and quality-control practices that must be in place. It applies to manufacturing, packaging, or holding operations. GMP is designed to mitigate the risks involved in any pharmaceutical production or creation that cannot be eliminated through testing the final product.

GMP covers all manners of production from the initial procurement, then the material manipulation, and finally the equipment necessary for the training and personal hygiene of staff involved. Detailed, written procedures are necessary for each process that could affect the quality of the end product. There must be systems and contingencies to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process and every time a product is made.

GMP considers a variety of specific areas including accounting, book-keeping, employee qualifications, cleanliness/sanitation, equipment verification, process validation, and dealing with complaints. Most requirements are general and open-ended, which allows the manufacturer to decide how to optimally implement the necessary controls and measures. This provides flexibility, but also requires that the manufacturer interpret the requirements in a manner that makes sense for each unique business.

GMP is also sometimes referred to as “cGMP”. The “c” stands for “current”, which reminds manufacturers that they should utilize technologies and systems which are modern in order to comply with regulations. Systems and equipment used to prevent contamination, mix-ups, and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.

Yes. Good quality starts with creating consistent production processes. Finished product testing can only verify the results of the processes, but the quality is only as good as the manufacturing process. GMP prevents errors that cannot be eliminated through quality control of the finished product.

Yes. When it comes to dietary supplement manufacturing GMP is now a requirement in the U.S. supplement industry. Ultimately, making poor quality products does not save money as it is more expensive to find mistakes after they have been made than it is to put good processes in place to prevent them in the first place. Moreover, poor-quality products can and will alienate your consumer base. GMP is designed to ensure that these kinds of mistakes do not occur.

If you want to find out more about 21 CFR 111 – GMP for Dietary Supplements you can review the full set of requirements here.