Quality Control and BRC
by Daryl DeLuca
Biotics Research has always practiced extensive Quality Control. Unlike many companies who are attempting to comply with the newly enacted GMP requirements established by the FDA, extensive Quality Control has always been part of our corporate fabric. Simply put, it’s part of who we are. In fact, many aspects of our cGMPs (current good manufacturing practices) exceed the FDA guidelines for dietary supplements. Please keep in mind, cGMPs are not some static set of practices; they are actually rather fluid. Challenges can (and do) arise, and it’s up to the Quality Control Unit (QCU) to adapt to meet those challenges. Additionally, we are always searching for ways to improve our QC practices, whether through new analytical methods or improved document control, Biotics Research is always looking for ways to improve the QC process.
At Biotics Research Corporation, the highly skilled members of our QCU utilize modern, sophisticated technologies and analytical methods to test incoming raw materials, monitor manufacturing processes, perform in-process testing, and test all finished products prior to their release for shipment. Our QCU has the authority to approve and/or reject all specifications and procedures associated with production and the release of all raw materials, packaging materials and finished products, including test methods and results, instrument calibrations and processing records. They conduct internal audits, establish and verify expiration dates, and validate and audit all raw material and packaging suppliers, as well as service vendors.
Dating is (and should be) an area of concern for healthcare practitioners recommending dietary supplements to their patients. Many companies use “Manufactured On Dates”. This means nothing from a quality perspective. They could be using raw materials that will expire the month after the product is made. Other companies don’t have any validation process for the ex-dates they do use. Why do companies do this? Many don’t have the capability to do the work, and make no mistake about it…establishing and validating expiration dates is hard work, time consuming and expensive. I see examples regularly of companies using 2, 3, and even 4 year ex-dating on products containing ingredients that are stable for no more than 12 months from the date of manufacture of the specific ingredient. How is this possible? Unless the raw material has been further processed specifically to extend its shelf life, it isn’t.
So be careful when selecting a dietary supplement supplier. If they are using a “Manufactured On Date” ask yourself why, and if a product from another supplier is a lot cheaper, it maybe because the product is a lot cheaper.
Daryl DeLuca is the Vice President and one of the founders of Biotics Research Corporation, a leading manufacturer of specially designed nutritional products for over 35 years, available exclusively through Healthcare professionals.