The Food and Drug Administration has recently defined its regulations for the Dietary Supplement Industry. These regulations place that industry under current Good Manufacturing Practices (CGMP) guidelines. This step, designed to assure a consistency of quality throughout the manufacturing and release of those products, has placed a greater responsibility upon those manufacturers.
Gibraltar Laboratories, a world renowned independent laboratory working under the same CGMP guidelines, has developed programs to meet with the federal guidelines. These programs are designed to help companies both new to the guidelines and those with quality systems already in place.
Some of the fundamental requirements that Dietary supplement manufactures may not be accustomed to are listed below. All of the below elements must be carefully documented and reviewed.
1 Vendor qualification
How do you handle domestic and international vendors under CGMP guidance?
2. Specification development programs
How do you determine what your raw material must have?
3. Raw Material analysis
Do your raw materials meet your specifications? What do you do when they don’t?
4. Analytical analysis of final products
Is what you have manufactured really what you want?
5. Microbiological analysis of final products
How do you control microbiological contamination in natural products?
5. Stability and shelf life (expiration dating) determination
How do you assure that your product will last once it is in the field?
6. CGMP consultation
Do you have a strong enough quality/regulatory program?