New CGMPs Make Product Testing a Key Factor in Manufacturing
By June 25, 2010, the dietary supplement industry concludes an event that will have historical significance. It would complete the last stage in a three-part installation of the FDA GMPs bringing a new level of high-quality standards for the entire dietary supplement industry.
The new rules and regulations under the cGMPs range from tighter manufacturing practices to detailed documentation, new personnel regulations and detailed product testing. Raising the bar on quality manufacturing will, no doubt, serve to enhance the image of the supplement industry. Consumers will have the confidence of knowing that the products they hold in their hands have undergone intense quality testing standards for manufacturing before being sold for consumption.
Product Testing and the cGMPs
In the past, the emphasis of product testing was on the finished product. Under the new GMPs, however, testing is used as a means of quality control. It begins prior to manufacturing with detailed documentation of finished product specifications, manufacturing processes and process controls and tests that would be used to ensure reliable results. Manufacturers must also specify the identity, purity, strength and composition related to raw materials used, specifying limits on types of contaminants that may adulterate or lead to adulteration of the end-product.
Testing and examinations must be set in place to ensure a controlled manufacturing environment, requiring the use of analytical equipment and the employment of additional professional personnel with extensive documentation at every level of manufacturing. While the type of testing is left to the discretion of the manufacturer, it must conform to valid scientific methods. The new regulations for quality testing of products may pose a problem for smaller manufacturers who want to continue producing high-quality supplements, but may not have the capital to invest in expensive analytical equipment and additional personnel.
GMP-Certified Manufacturing Facility
One sure way such manufacturers can keep their products flowing in the market is through contract manufacturing with private label supplement manufacturers that have a fully-equipped lab with analytical equipment and a GMP-certified facility. Vitacap Labs, a superior-quality private label vitamin manufacturer, has already had their manufacturing facility certified by the NNFA, a third party GMP certifier and was more than ready to meet quality standards of the cGMPs. Besides superior-quality manufacturing, a unique advantage with Vitacap Labs is the option of placing small order quantities-with minimum orders starting at just 96 bottles! In addition, they offer you the freedom to mix and match any combination of their stock formulas to meet this minimum! Facilitated by high-speed, advanced machinery, 100 percent satisfaction is guaranteed to meet your pre-specified manufacturing, packaging and delivery requirements.…