Pharma-IQ™ Manufacturing

What is Pharma-IQ™ Manufacturing?

In a loosely regulated supplement industry plagued with controversy and poor quality controls, Pharma-IQ™ is a mission-critical quality program developed under our Space Act Agreement with NASA to ensure consistency, safety and efficacy.

From raw material to finished product, Pharma-IQ™ is a Spinoff technology that goes beyond current regulatory guidelines, and requires extensive batch controls and laboratory testing.

Understanding GMP

Good Manufacturing Practices (GMP) refers to a collection of guidelines that manufacturers, processors and packagers are required to follow in order to ensure adequate standards of quality for certain types of consumer products.

GMPs for the pharmaceutical industry have been in place for decades, and have proven quite successful at ensuring consistency, safety, potency, bioavailability and purity. Whereas mislabeling, contamination and adulteration used to be commonplace in the early days of modern medicine, since GMPs were adopted in the 1960’s, there have been but a handful of prominent drug adulteration cases impacting public safety.

The food industry also has its own set of GMPs. But their purpose is different: whereas pharmaceutical products are meant to be safe as well as efficacious, food products are only expected to be safe. There are no standards of “efficacy” mandated in Food Industry GMPs.

It may surprise many to know that until the year 2010, most dietary supplement companies were not required to comply with supplement-specific Good Manufacturing Practices. Perhaps more significantly still, these newly imposed GMPs that came into effect for the supplement industry in 2010 were modeled after the GMPs of the Food industry – not the pharmaceutical industry.

Why is this important? Because fundamentally speaking, Food GMPs are only intended to ensure that the end product is safe. Yet, while dietary supplements are indeed food items intended to supplement the diet, their inherent purpose is different from that of, say a can of baked beans or a bag of potato chips.

Dietary supplements should meet quality standards that ensure consistency, purity, potency, efficacy, and the ability of the product to deliver/dissolve its contents – in addition to safety.

Pharma-IQ™ Requirements

Modeled after pharmaceutical quality control systems, Pharma-IQ™ goes several steps beyond current Good Manufacturing Practices, and requires extensive batch controls, ingredient testing, potency assays and record-keeping, to name a few – often exceeding existing requirements for pharmaceutical products.

Documentation Controls

We abide by the old adage: “if it’s not documented, it didn’t happen.” Every step of the production process, whether raw material selection, tablet compression force, or test results, must be documented. Quality Unit inspectors review and approve production and testing procedures, forms, and records before a lot of finished product is released.

Ingredient Selection

Each individual raw material is positively identified using “fingerprinting” (e.g. FT-NIR) or other validated methodology. Suppliers must provide Certificates of Analysis on every component shipped, before it is accepted. Then, the material is tested in-house to ensure compliance and absence of contaminants.

Laboratory Analysis

In addition to ingredient testing, each product is tested at various stages to ensure:

• Homogeneity (e.g. consistency across the entire batch),
• Potency (e.g. each ingredient meets the label claim),
• Purity (e.g. heavy metal, microbial, and other forms of contamination),
• Dissolution (e.g. the contents are released and become bio-available)
• Stability (e.g. ensures freshness throughout its shelf life)

Third-Party Validation

To provide an objective and unbiased verification of our quality beyond our internal protocols, Pharma-IQ™ also requires the independent validation of both the product and the facilities. As such, we voluntarily submit random samples to FDA-approved third-party laboratories to corroborate test results. Furthermore, we also require independent facility audits conducted by certified pharmaceutical auditors such as NSF, USP, and BSCG.