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Title 21 CFR Compliance for Dietary Supplements

Introduction

Every manufacturer of consumable products must be registered with the Food and Drug Administration (FDA) and the Department of Agriculture (DOA). cGMP is the regulation set forth by the Federal Government for the guidelines enforced by the FDA creating compliance requirements for companies manufacturing supplements for distribution and sales to the general public. It is important to note that the FDA does NOT certify companies in the cGMP standard, it is an auditing body to enforce compliance. The DOA audits for general cGMP compliance annually and maintains these standards as a general compliance with spot auditing by the FDA. There are services available for advice and inspections for the confirmation of compliance by law firms and companies claiming to provide these certifications. It must be understood that these companies are not responsible. Using a qualified licensed law firm is suggested. The manufacturer is the responsible party and the service is only as good as the company providing the service.

Compliance Impact

Each and every company manufacturing supplements must comply with cGMP requirements. Failure to do so may result in various outcomes, not limited to catastrophic fines, assessments or even immediate shut down depending on the violations at hand. Failure to comply will result in further penalties, fines and even jail time may be issued as a result. Companies claiming to meet these standard without general compliance can also be faced with serious penalties. Making these claims or noncompliance with claims will eventually result in shut down. Because of the FDA having budget limiting issues, many companies survive for extended periods, but the results are inevitable.

Re-Seller Responsibility

It is the responsibility of each retail and wholesale re-seller of products to either demand a certification of compliance from each company supplying products or be responsible for the consequences. It is only good business to follow these regulations and ignorance is no excuse for the law. Being notified or not being notified by the governing bodies of non-compliance, professional and personal liability to lawsuits and attacks could be eminent. We urge all companies to meet these requirements.

General Process Compliance

Developing a cGMP `program is a multimillion dollar process to develop. The Standard establishes the safety the public demands. Disagreements and potential easements of the strict regulation are continually being discussed but continued compliance will always be a kept requirement. Below are the basic requirements of cGMP. In no way does this even begin to describe the complete requirements.

Property and Construction

The interior and exteriors of the property must be maintained in a groomed and germ-free atmosphere which clearly limits cross contamination from any other processes and changes in use at all times. This includes clean parking lots, maintained foliage, proper layouts of the rooms and limiting access directly from the outside. All walls and ceilings in processing areas must be washable surfaces. Floors are installed in such a manner wherein crevices and cracks leading to bacteria growth are obsolete. Locker rooms must be accessible prior to any processing. Separate lunch areas and dressing rooms must be provided. All facilities must have 3 bay sinks large enough to clean the larges piece of parts with separate mops sinks and hand sinks in every production room. A minimum of 20% filtered outside air must be designated in. In many cases buildings and rooms need to have air quality testing conforming to much stricter air quality standards. Complete control over entering, leaving and maintaining air quality is required.

Need an attorney?

On request, Atofil provides an attorney review to confirm compliance. We have to meet a GMP standard, upholding excellence in everything we do. Therefore, we are happy to audit your product through our legal team to ensure you are compliant. Compliance is a foundational principle of our Atofil operation.