CADEN CARTER
Carter Regulatory Group, Utah, USA

Abstract

When working with contract manufacturers, you are responsible for the quality of your product. You, as the distributor, have the responsibility to know how your product is made. Performing an audit of your contract manufacturer is vital to ensure quality. Audits should be performed prior to selecting your manufacturer and may include on-site audits, desk audits or documentation audits, or 3^rd party audits. As you understand key items to look for, you will understand more about your manufacturer, making your audits insightful and successful. This will help you make a quality-based decision when selecting your contract manufacturer or co-packer. With a sufficient quality agreement and continued involvement, you will be able to have faith in the quality of your product

The United States Food and Drug Administration (FDA) has made it clear that a distributor of a food or dietary supplement product “has an obligation to know what and how manufacturing activities are performed so that the distributor can make decisions related to whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution.” (1). In order to have faith in the quality of your product and also to remain compliant with regulation, you may need to have the conversation with your manufacturer or co-packer:  it’s time for an audit.

TYPES OF AUDITS

There are three basic types of audits you can conduct of your Contract Manufacturer or Co-Packer (collectively referred to as CM):  on-site audits, desk audits/documentation audits, and 3^rd party audits.

On-Site Audits

On-site audits of a CM are the preferred method and will provide you with the most information. An on-site audit should include a walkthrough of the facility as well as ...