AstaReal USA Earns Prestigious GMP Certification from NSF International
BURLINGTON, NJ – AstaReal USA has announced it has obtained NSF International Good Manufacturing Practice (GMP) registration for its processing facilities in Moses Lake, Washington, making the supplier the first and only manufacturer of natural astaxanthin that has this registration.
Arun Nair, CEO of AstaReal USA, commented, “AstaReal has pioneered in setting gold standards for quality and science in the natural astaxanthin space. We have seen several suppliers in the industry steal our science from public domain to corroborate their brands and confuse customers with alleged certifications lacking evidence. NSF GMP registration puts us in a different league. NSF GMP registration validates our commitment to continued compliance of Good Manufacturing Practices required by the U.S. Food and Drug Administration (FDA).”
Earning GMP registration from NSF International verifies that AstaReal’s facility has the proper methods, equipment, facilities, and controls in place for producing dietary supplement products. NSF GMPs were developed in accordance with the U.S. Food and Drug Administration’s (FDA) 21 CFR part 111 regulations for the manufacturing, packaging, and distribution of dietary supplements. Utilizing GMP guidelines assists companies in developing and maintaining proper controls in their manufacturing process so that products are processed, manufactured and labeled in a consistent manner, and meet quality standards.
“NSF International welcomes AstaReal USA as a GMP registered facility,” said Dr. Cheryl Luther, General Manager, Dietary Supplement Program, NSF International. “NSF International is the leader in dietary supplement GMP facility registration and AstaReal USA joins over 630 NSF GMP registered facilities who have met the requirements of the most rigorous GMP program available.”
Joe Kuncewitch, AstaReal USA’s National Sales Manager, added, “Having attained GMP registration by such a prestigious organization as NSF International highlights the emphasis AstaReal puts on our manufacturing practices. No other natural astaxanthin producer has attained the scope of global quality registrations that AstaReal has, and this is further demonstration that AstaReal is absolutely committed to achieving manufacturing excellence.”
Nair pointed out that AstaReal’s plant and manufacturing facility had to undergo rigorous tests and quality assurance before NSF International considered the company to move forward to achieve GMP registration status.
AstaReal USA’s combined expertise and experience in the production of microalgae (and specifically Haematococcus pluvialis) allows the company to offer the highest amount of astaxanthin per kilogram of biomass. H. pluvialis is grown in stainless-steel photobioreactors under carefully and fully controlled indoor conditions that enable a more effective, cleaner and safer process.
Kuncewitch noted that the new NSF GMP registration can also translate throughout the chain to the consumers, who now expect transparency and responsibility. “Consumers want to know where the ingredients in their supplements, foods and cosmetics come from, and if those ingredients are manufactured in facilities that follow rigorous safety and quality control measures. AstaReal astaxanthin is the only brand that fits the bill.”
NSF International is a global independent organization that writes standards, and tests and certifies products for the health sciences, water, food and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. Operating in more than 165 countries, NSF International is a Pan
American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
The NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP analytical testing, DNA testing, certification, R&D, regulatory guidance and corporate compliance for the pharma biotech, medical device, dietary supplement and bottled water/beverage industries throughout the product lifecycle. NSF wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifiesproducts to this standard.