fda “good manufacturing practices” (gmps)
The much-anticipated FDA “Good Manufacturing Practices” (GMPs) come as welcome news to some and maybe not so welcome news to others. In either case, for those organizations, which manufacture, package, and hold dietary ingredients or dietary supplements, the new proposed GMPs are on the doorstep knocking at the door of the Dietary Supplement Industry.

There are many issues to sort out. It may be an understatement to say that the new proposed rule may be slightly confusing. To summarize briefly: The purpose of the FDA GMPs are to assure the consumer that the manufacturing process display, consistently, the identity, purity, quality, strength, and composition of dietary supplements.

Minimum Standards for design and construction of physical plants include:

• Proper Maintenance
• Suitable Cleaning
• Manufacturing operations
• Quality Control
• Testing final product or incoming and in process materials
• Handling consumer complaints
• Maintaining records

Chemical Solutions Ltd. (CSL) is capable of assisting you with testing either your final or incoming and in process materials. CSL has over six years experience in trace elemental analysis of natural products. In establishing the purity and quality of your materials, CSL is able to analyze your material for the contamination of heavy metals individually with the detection capability of inductively coupled plasma – mass spectrometry (ICP-MS). Detection limits range from low ppm to possibly the ppb level. In addition, CSL is capable of examining your mineral products for essential minerals and elements. In the coming months, CSL is adding microbiological testing services, to, support the dietary supplement industry.

The comment period has been extended to August 11, 2003. In what ever form the new FDA GMPs take, testing of ingredients or products will exhibit a significant role in the future of the dietary supplement industry. Please contact us for assistance regarding your analytical requirements.