Short Link to this Page:  https://tinyurl.com/spigmp

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With return to the regulatory state in the Biden/Harris Administration, no doubt the FDA will continue to increase its pressure on small to medium vitamin companies to move their control systems further in the direction of pharmaceutical-style controls.  Not all of these companies have the foresight to afford such control systems, thus, those who survive will be those who can adopt sufficient controls to meet increasing regulatory standards soon enough.

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The Vitamin Consultancy is aware of the trend in such standards as we receive constant communications from the industry regarding FDA inspections and 483 Observation Reports.  We also review published FDA warning letters. We are aware that FDA says that product Label Owners “must be in a state of control” over all of the processes that result in the product reaching the consumer.

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The Stages of the Process include: 

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Specifications
Raw material acquisition
Manufacturing
Bottling
Labeling
Storing
Shipping
Customer service.

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To enable proactive companies to meet the higher standards we established Systems Processing Integration.

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The first stage in the SPI concept is the Regulatory Compliance Website (RCW). 

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We have designed and implemented for select clients, a private, password-protected website that compiles all of the required regulatory documents online to enable quick and efficient responses to FDA inspections.  They are also often useful for management control over marketing communications.

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These Regulatory Documents include:

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Branding Dossier
Standard Operating Procedures (SOPs - with commonly used forms)
Core Company Data Sheets for each product
Specifications for each product
Structure and Function Notices, with label copies, for each product.
Training Certifications:  SOPs, GMPs, QC, PCQI
Homeland Security/FDA Food Processing Registration

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Just when managers need access to their core product and marketing documents is just when they can be difficult to find -- for example, during a flood, or during an inspection.  The SPI system centralizes those key documents and makes them readily available to management.

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The Second Stage in the SPI concept is the Regulatory Tracking System (RTS).

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This carefully constructed computer program tracks all of the core data for each product and each product batch. Based on state-of-the-art manufacturing and warehousing control systems that can be very expensive to implement our RTS system is tailor-made for small to mid-sized dietary supplement and natural food product companies and can be reasonably easy to customize for the particular needs of the company.

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Essentially the RTS tracks all products across all recordable factors, relating each to the Stages of the Process and to Regulatory Documents.

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RTS thereby creates and maintains the contemporaneous logging of system processing activities that FDA requires.  As FDA states, “If it is recorded (logged) that is what happened; if it is not recorded (logged) it did not happen.”

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SPI offers an array of products to meet various company needs.

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The initial product is the RCW

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This website is needed prior to the development of the RTS system and guides its implementation.  The RTS, depending on complexity, costs from $2,500 and requires two weeks for implementation, from the time the company provides the necessary Regulatory Documents.

 

Maintenance is included in the monthly RTS maintenance fee.

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A secondary product is guidance training.

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The Vitamin Consultancy also provides guidance for the production the Regulatory Documents and has a time-tested SOP format which can be fine-tuned for the company’s needs. 

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FDA tells us that it is not enough to have careful SOPs. The staff must be trained in using them and the company needs to be able to show that training occurred.  Our 25 training webinars and ebooks meet regulatory standards. We provide appropriate training certifications.

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The cost of this consulting process varies and is based on a $250/hour consulting fee.

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Finally, the RTS unifies all regulatory efforts.

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This complex tracking system meets FDA batch record and logging requirements.  Depending on complexity, the system will cost from $15,000 with a monthly maintenance fee from $500.  It takes about six weeks to implement.

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Let our half century in the nutrient business guide your game plan to meet and exceed ever-evolving regulatory requirements.

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Sample Private Regulatory Compliance Web Page

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