Manufacturing Archives - Priority One Vitamins Blog

Understanding Glandular Sources and Animal Health

First, 90% of Priority One’s glandular’s are sourced from Denmark, and unlike Australian, or New Zealand glands, Denmark is the only country that has been antibiotic, and growth hormone free for all bovine and and porcine glands since 1998. This means that our glands are pure, untreated, and retain the best balance of naturally occurring hormones available on the market. glandular-sources-2014

Second, we source farm to processor, this means that not only do we have the ability to trace our glands to the country, but we retain all of the veterinarian release forms, that trace each and every animal to the farming region, and processor in which they were obtained from. This not only assures us that the glands are indeed from Denmark, but it also assures us that the glands are handled in a timely fashion, allowing them to retain the optimal freshness before processing. Most companies can not trace their glands beyond the country or region of origin.

Third, The link between antibiotics in the food chain and human resistance is striking, look at this quote: from a recent CBS report on Denmark and their success in removing this danger from the food chain.

” I think the Danish and European experience indicate that there will be real and measurable public health benefits,” she said. “There’ll be improvements in food safety and actually in the prevalence of drug resistant infections in people.” says Dr. Ellen Silbergeld

Finally, here is the link to the Australian viewpoint on antibiotics in their meat processing, and food chain, just as an excerpt, it clearly states that they feel it is highly unlikely that antibiotic resistance can develop from antibiotics in the food chain, and that farmers use antibiotics for the health of the animals. Australia’s viewpoint on antibiotic use in animals in the food chain.

Danish Porcine Producers and Food Safety

Danish Porcine Industry Quality Manual pg-116-117

Priority One Nutritional Supplements, Inc.

Full Label Disclosure

R.E.M. Priority One is the only company on the market with a complete label
disclosure policy.

This means we require our raw material suppliers to provide us with flow charts and full disclosure of process materials so that we in turn can disclose this to you the customer! If a supplier chooses not to submit these documents our quality control personnel reject these incoming raw materials and they are not allowed in our Priority One product line.

Most companies limit their disclosure to only ingredients actually added at the time of manufacture, this as you will learn in later posts is not the whole picture, allergens, glutens, animal products and preservatives have all been found by our quality control department at the review stage and these ingredients have been rejected for use. Does your supplement company have this type of commitment to quality?

Priority One Vitamins Labeling — Priority One Vitamins Thyroid 65mg Labeling

Priority One does not try to mislead the physician or patient in the labeling of our supplements. Since we manufacture in house and source our own raw ingredients we are able to know exactly what is in our products and make sure you do also!

For a label to label comparison I will be updating this post in the next few weeks so stay tuned, and you will see examples of what other supplement companies are refusing to show you on their labels!

Danielle S. Baumgart, President

Priority One Nutritional Supplements Inc

A Peek Into Our Rigorous Vendor Approval Program

We call it a Hazard Analysis Review

Because no matter how good your sources are all ingredients and companies have inherent hazards and it is our duty to protect our customers from these, and to provide the best ingredients available from the best sources.

Priority One maintains a robust hazard analysis program that reviews the potential for risks associated with each manufacturer of ingredients following NSF guidelines.

First, four members of our quality team review the quality program of a potential vendor, utilizing physical audits, interviews, testing method validations, and background checks for past or current regulatory issues.

Next, all compiled information is brought to a classification session. During this session, a review of the documents and ingredients supplied by the potential vendor is conducted.

Potential hazards are proposed such as country of origin, inherent ingredient hazards (mold, E. coli, Salmonella…) or economical adulteration potentials.

After all potential hazards have been agreed upon and classified, the probability of such hazards occurring is determined, using a classification from frequent (1 in 5 purchases) all the way down to extremely unlikely ( 1 in 10,000 purchases). These are determined by scientific methods, observations, real-life testing protocols, and industry inside knowledge of economically generated adulterations. Last, using the severity and probability, a risk level is determined.

By determining the risks and risks levels of a potential vendor we can identify testing protocols and mitigations even for the best of vendors to ensure that they maintain their quality standards, and by validating their quality before they are approved for use we are able to eliminate substandard vendors and their ingredients from our process.

Remember your end result is only ever as good as the sum total of the quality of your ingredients.

danielle

Danielle S. Baumgart, President

Priority One Nutritional Supplements Inc

We offer tours of our Quality! I mean factory……

Businessman with an open hand ready to seal a deal

When I say quality is an action word, I really mean it. This isn’t a glossy advertisement it is quality at work everyday with every product, and every employee. I am proud to say we are a third generation privately held company, and our family would love to show you what we do every day that makes us different than our competitors.

front-of-our-facility

Yes we have an open door policy, we recommend touring and visiting our facility. We find that this helps physicians and students become more familiar with the manufacturing process as well as the terminology that comes with the manufacturing process. We feel it gives physician’s a strong voice in answering their patient’s questions. Such as where their supplements come from and details of the manufacturing process. We would be happy to familiarize you with CGMP or current good manufacturing practices, and labeling guidelines. As part of their education many students have toured our facility.

bastyr-touring-students Students, from Bastyr University, NUNM, and SCNM as well as many many practitioners have already enjoyed visiting us yearly, please we extend you a warm welcome……be our guest.

Danielle S. Baumgart, President

Priority One Nutritional Supplements Inc

danielle

Quality isn’t glossy advertisements!

Everyone screams quality when talking about dietary supplements. Pestle and Mortar with Herbal Complementary Medicine

Learn how to ask the right questions about vitamin quality, herbal purity, and sustainability.

Throughout this blog I hope to lead you down this path in understandable, non-governmental language.

Dietary Supplements are a type of food product for which specific food CGMPs (Current Good Manufacturing Processes) are needed. I think everyone would agree with that.

Manufacturing process controls are needed to ensure that a dietary supplement contains what the manufacturer intends.

Process controls must be in place to ensure the tablet or capsule contains what it purports to contain and are different than those that must be in place to ensure a food is manufactured, processed, packed and held under sanitary conditions.

The FDA is the governing administration that oversees the dietary supplement industry and rightfully so, without oversight those who wish to create safe, effective supplements are crowded out by those who solely wish to make a profit, at the public’s expense. As an industry we need process control, we needed something to control the quality of supplements and foods coming on the market. CGMPs or current good manufacturing Portrait of smiling scientist holding a clipboard practices are essential to this.

In order to achieve consistency and reliability, there must be process controls in place to ensure for example, that appropriate tests and examinations are conducted, a master manufacturing record is prepared, each batch production follows the master manufacturing record, and the finished tablet or capsule is placed in the intended package with the intended label.

Well-established principles of CGMP require controls at each step of the manufacturing process as early in production as possible. Quality cannot be tested into a product at the end. Instead the quality of the dietary supplement must be built into the product. Each step of the way, by every workforce member who touches it. scientist observed green leaf in laboratory glass

It is not sufficient, nor effective, to rely solely on end product testing to assure the quality of the individual dietary supplement product sold to the consumer.

CGMPs are intended to establish a comprehensive system of process controls.

Manufacturing according to CGMP means that the manufacturing process incorporates a set of controls in the design and production processes to assure a quality finished product. Highest quality assurance, high quality level guarantee

The term “quality” comes up repeatedly in comments in the dietary supplement industry. Quality is more than a glossy marketing advertisment. Quality related to dietary supplement industry is having identity, purity, strength and composition intended for each specific batch. And being able to prove this with available documentation.

Flowers and plants in test tubes We agree that a critical aspect of CGMP is achieving control over the manufacturing process. Controls are necessary to ensure that you manufacture what you intend so that the characteristics and/or attributes desired in a final product will be consistently and reliably achieved.

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Many companies claim quality, but true quality requires continual action. Our full-service CGMP manufacturing facility is certified under 21 CRF Part III. We truly care about what is happening in your practice and strive to support you and your patients with clinical strength supplements that you can have confidence in. We have been inspected by FDA many times and with each inspection we gain further knowledge and understanding for improving our processes.

Vitamins

So next time you see the word “quality” being used in advertisements, ask yourself what is the record, can they stand by this claim, and if asked can they produce proof that they are a Quality manufacturing company.

Sincerely,

Danielle S. Baumgart, President

danielle