The MegaCare Quality System is an evolving set of principles that guides the Company in all her endeavors as a Manufacturer and Marketer of Dietary Supplements. These principles include:
1. Honesty and Integrity. We promise to fully vet all materials we release, ranging from marketing statements to label claims. And if we’re wrong, we’ll admit it.
2. Science. We promise to base all of our manufacturing and marketing practices on science. This means we will implement improvements and corrections based on recorded observation and experimentation.
3. Compassion. We promise to focus on the pressing needs of the community, with greater emphasis on the less fortunate.
In our industry, a Quality System is defined as a set of practices that a Company follows to ensure the manufacture of safe and unadulterated product. The United States Food and Drug Administration (FDA), which was formed out of urgent need (see Upton Sinclair’s The Jungle or the 1937 Sulfanilamide Elixir Incident), issues rules known to the food and drug industry as the Code of Federal Regulations (CFR) Title 21. For the Dietary Supplement industry, companies like ours must follow CFR Title 21 Part 111 Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Herein, CFR Title 21 Part 111 is referred to as the Rules.
These Rules govern Personnel, Facility, Equipment, Utensils, Production and Process Control System, Quality Control, Records, Holding, Distribution, Returns, and Product Complaints. In the simplest terms, the Rules represent the bare minimum standards a Company is expected to follow in order to protect public health.
What are some of the things we do at MegaCare that ensure product safety and purity?
1. We have an excellent relationship with our Ingredient Suppliers, most of whom we have used for more than 20 years now also comply with FDA cGMP on ingredient quality control.
2. We perform an array of laboratory tests, both in-house and with contract labs, to ensure safety and purity of product. Some examples include
a. Near Infrared Spectroscopy to identify Ingredients received
b. Microbiological tests for Yeast, Mold, E. coli, Salmonella
c. Heavy Metals tests for Lead, Mercury, Arsenic, and Cadmium d. Physical properties tests and contamination prevention observation. Any ingredients that are not complied with specifications and doubt of being contaminated are returned to vendors.
3. We are regularly inspected by the Nevada State Health Division and US FDA.
4. We regularly attend in industry conferences (such as SupplySide West) to stay on top of current innovations and challenges.
5. We listen to our valued Partners and Customers.
In summary, the MegaCare Quality System starts with
(a) the folks that raise the botanicals for harvest; to
(b) the folks that process the active botanicals into well-designed dosage forms; to
(c) the folks that test the product for contaminants; to
(d) the folks that listen to the MegaCare family seeking advice, issuing product concerns, or sharing success stories (our FAVORITE!); to
(e) the folks that implement corrections and improvements based on real-time results.
It’s really all about the people, and we are fortunate to blessed with the talented and caring folks that comprise the Company, its Partners, its Inspectors, and most of all, you!
In Good Health,
Joe Su, PhD