As a supplement brand, you have probably heard the terms "GMP regulations" or "GMP contract manufacturing." If you are not familiar with these regulations, may be wondering why GMP certification is so important. Below is some information to help you understand GMP contract manufacturing regulations, their purposes and their benefits for supplement brands and consumers.
What Is GMP Contract Manufacturing?
GMP, which stands for "Good Manufacturing Practice" regulations exist to make sure that manufacturing companies keep to a strict ethical code at all times and produce safe, good quality products. These regulations impose requirements on packagers, processors and manufacturers of food, drugs and medical devices.
When companies fail to conform to GMP regulations, they may face certain penalties. Possible penalties for infractions include fines, recalls, seizure of the company and even jail time for individuals responsible. The existence of these penalties ensures that manufacturers have incentives to follow the rules and remain in compliance as much as possible.
Supplement manufacturers who comply with GMP regulations fully can become GMP certified, which sets them apart from the competition. However, full compliance can be difficult. One of the requirements, for example, is shelf-life testing. This type of testing, which the FDA requires contract manufacturers to complete, shows stability data and allows the manufacturer to provide a valid expiration date on all of the products they sell. Unfortunately, this type of testing is involved and expensive, so some manufacturers are not able to complete it effectively.
Why Do We Need GMP Regulations in the Supplement Industry?
GMP regulations allow supplement brands to look for a manufacturer without worrying that the company is not creating good products or complying with certain ethical standards. Instead of investigating each manufacturer individually, supplement brands can simply look for manufacturers like ABH Pharma who are GMP certified and know that they are meeting all of the relevant requirements.
Do All Manufacturers Follow GMP Regulations?
As an industry, supplement manufacturing has made great improvements in its level of GMP compliance. However, some manufacturers still commit infractions. A recent review of FDA cGMP inspection records showed that most manufacturers are generally in compliance with the intent of these requirements. When manufacturers are not complying fully with GMP requirements, minor technical details are usually the problem, such as minor recordkeeping issues.
Even though compliance is improving, there is still room for improvement. Unfortunately, many of the supplement manufacturers who are not meeting the requirements of all GMP regulations have a hard time bringing their facilities into compliance because of lack of training, lack of expertise or resource limitations.
Some of the most common infractions that have led to warning letters from the FDA include infractions related to procedures and documentation, cleanliness, product complaints and returned goods, quality control, batch records, master manufacturing records, identity testing, specifications and obligations of private label distributors.
What It Means for Supplement Brands
As a supplement brand, you need to be sure that your manufacturer is following all of the relevant GMP contract manufacturing regulations. Before choosing a manufacturer, make sure the company is GMP compliant. It is also a good idea to visit the contract manufacturer's facility to see things for yourself. To ensure continuing compliance, conduct regular audits of your GMP contract manufacturer throughout your relationship.
Working with ABH Pharma
If you are looking for a supplement manufacturer who can meet all of your needs while complying with all of the latest contract GMP regulations, look no further than ABH Pharma. ABH Pharma is in full compliance with current Good Manufacturing Practices. As one of few supplement manufacturers that complies fully with these guidelines and is GMP certified, we can ensure that every product your customers receive is safe and of the best possible quality. In fact, ABH Pharma just celebrated its receipt of the NPA UL GMP Certification. Unfortunately, many of our competitors fail to acquire this certification because of the associated costs and level of effort required.
ABH pharma is a full-service supplement manufacturer that offers a wide variety of products and services for supplement brands of all sizes. Some of the services we offer include powder manufacturing, softgel manufacturing, tablet manufacturing and capsule manufacturing. We offer both custom supplements and stock supplements. We can handle all of your manufacturing needs, from the selection of ingredients to custom packaging design. We also provide warehousing and fulfillment services. Please contact us today to learn more about our services or to discuss your needs in detail!
