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A Quality Story
   
The Quality Quandary
Throughout the dietary supplement industry, the vast majority of manufacturers tout product quality as the cornerstone of their business. But true quality is often lost among mystifying claims. Integrative Therapeutics believes the answer is simple.
Understanding Industry Standards & Limitations
Throughout the dietary supplement industry, the vast majority of manufacturers tout product quality as the cornerstone of their business.
But true quality is often lost among claims of specialized processing techniques and formulation secrets, special certification and accreditation titles, and continual in-fighting, all of which adds layers of confusion to a complex and often misunderstood industry. Practitioners and patients are left wondering, how do you define a quality manufacturer?
We believe the answer is simple: the true measure of quality is found in the GMPs.
What Good Manufacturing Practices (GMPs) Mean to You
GMPs are one of the most critical definitions of quality.
Because of their inherent importance, GMPs have seen a number of changes in recent years as practitioners and patients demand greater oversight of supplement manufacturers.
While supplements were originally regulated under Food GMPs, the FDA has now established Dietary Supplements GMPs [Title 21 Code of Federal Regulations (CFR) Part 211]. And while the new GMPs are a great step in the right direction, there are still areas where they fall short:
- Every lot testing
- Expiration dating
- Bioavailabilty analysis
Two additional issues largely ignored are the timing of compliance and the auditing process; manufacturers have been given ample time to become compliant, and the FDA may have limited resources to monitor manufacturer quality on so large a level. Only a few companies, such as Integrative Therapeutics, hold themselves to higher operating standards as Food and Drug Administration (FDA)-registered drug establishments [21 CFR Part 210 and 211].
Meeting or Exceeding Requirements for Years
Only FDA-registered drug establishments are required to document all aspects of manufacturing, confirm product efficacy, and ensure consumer safety through rigorous testing.
FDA inspection of such facilities is an intensive experience (generally 3-4 days of auditing) and typically an annual requirement. See table below which compares GMPs for foods, dietary supplements and drugs.
At Integrative Therapeutics, we have been meeting or exceeding drug requirements for years.
Comparing and Contrasting GMPs
| Requirement |
Dietary Supplement |
Drug |
What Drug BMPs Mean to You |
| Documentation |
Moderate |
Immense |
Safety and efficacy are top priority through every step of the process - from ingredient to production through testing and beyond. |
| Testing |
Subset |
Every Lot |
Safety and efficacy are verified on every lot - you get what you pay for batch to batch, bottle to bottle, and capsule to capsule |
| Stability |
None* |
Required |
Product remains effective throughout shelf-life - not just 'at time of manufacture'; expiration date is required |
| Validation |
None |
Required |
Product consistency from batch to batch |
| Timing of Compliance |
2010 |
Now |
Every product you purchase meets the highest quality and safety standards |
Serious Certification: FDA Drug Establishment and Certified Organic Processor.
Integrative Therapeutics has maintained an FDA Drug Establishment registration since 1996 (registration #2128693: last audit 07/09, and has more recently been certified as an organic processor (organic #106450A: last audit 02/09).
Secondary Certifications:
UK’s Medicines and Healthcare Products Regulatory Agency
The MHRA is the United Kingdom’s government agency responsible for ensuring that medicines, herbal medicines, homeopathic remedies and medical devices work, and are acceptably safe. ITI is the first US supplement company to receive the prestigious MHRA Drug Good Manufacturing Practice (GMP) certification.
NSF International, the Public Health and Safety Company™
NSF is an independent, not-for-profit organization that support regulatory standards through onsite audits and inspections. The ITI manufacturing facility has received the NSF GMP Certification.
Quality Assurance International (QAI)
According to the USDA, the term ‘organic’ means an ingredient is produced by famers who emphasize the use of renewable resources and the conservation of soil and water to enhance environmental quality for future generations. ITI products are manufactured in a facility that has been certified as an organic processor by QAI, a USDA accredited certifying agent.
The quality we have come to love in ITI is like a good seat-belt. We don't have to spend time thinking about it to know that it won't let us down. Instead, it allows us spend our time and focus on driving that proverbial 'road to health' with our patients.
Drs. Cari Thachuk and Heidi Hook
Naturopathic Physicians | Auburn, CA
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GMP STANDARDS
What to look for in GMP standards
√ FDA-Registered Drug Establishment - above and beyond dietary supplement GMPs
- Registration number and copy of certification
- Last audit date & regular audit schedule
√ Secondary certifications
- GMP (SNF, TGA, etc)
- Organic and kosher
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