GMPs (good manufacturing practices) are critical for meeting safety and legal requirements for dietary supplements made in the United States, yet, FDA still finds most firms aren’t meeting all of the obligations. Per FDA audits, the most common violations include lack of specifications, not verifying suppliers, and incomplete master manufacturing records (MMRs). However, brands that carefully review their standard operating procedures (SOPs) can help ensure they meet all the requirements.
In this episode, Joy A. Joseph, chief operations officer, Joys Quality Management Systems, and Sandy Almendarez, editor in chief, INSIDER discuss:
- The importance of establish product specifications
- The information that needs to be included in MMRs and batch production records (BPRs)
- FSMA’s preventative controls and how they affect manufacturing of dietary supplements
Joseph will be speaking on GMP Compliance for Supplement Manufacturers at SupplySide West as part of the Workshop: Contract Manufacturing: Raising the Bar on Delivering Quality on Saturday, Oct. 8 at 8:30 a.m. Visit supplysideshow.com for more information and get registered. This session is underwritten by Paragon Labs, National Enzyme Co., Bio-Energy Systems and BASF, the official education sponsor of SupplySide West.
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