AssurX, Inc.'s Compliance Management Solutions Address New Mandatory FDA Quality And Regulatory Requirements For The Vitamin And Supplement Industry

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•Product Sheet: CATSWeb Enterprise Quality Tracking System

The FDA has just issued a final rule establishing regulations to require Current Good Manufacturing Practices (cGMP) for dietary supplements. These new regulations become effective August 27, 2007, with an allotted three-year phase in plan for small businesses. The FDA established this rule after numerous years of evaluation and discussion with the industry. The new regulations focus at ensuring the quality of dietary supplements so consumers can be confident that the products they purchase contain what is on the label. Previous regulation of Dietary Supplements (DSHEA) basically only required supplements to be controlled like food products whereas now they are controlled more like a drug product, but not quite to that same level.

In recent years, the FDA has clearly exhibited a more public emphasis on supplement enforcement. It has taken many forms, not the least of which have been a series of highly-publicized hearings on Capitol Hill demanding stronger FDA oversight of steroids and supplements such as the sometimes contentious July 2003 hearings on ephedrine alkaloid containing dietary supplements before the House of Representative's Subcommittee on Commerce, Trade and Consumer Protection. Democrat control of the House in 2006 has also already increased the number of times FDAers have been called to testify and sometimes defend their role in handling supplements. With lawmakers keeping more of an eye on the FDA, it is likely the FDA will increase its own vigilance when it comes to the enforcement of supplements.

These new regulations (21 CFR Part 111) require a firm to address an array of elements that include, but are not limited to:

• Personnel qualification and training records
• Equipment logs and calibration records
• Supplier management
• Deviation and investigation actions/records/follow up
• Written procedures
• Complaints management
• Reporting adverse events to FDA
• Returned material handling

Failing to follow FDA regulations is a serious matter and is a prohibited act as cited in the Federal Food, Drug, and Cosmetic Action Sec 301 [21 USC 331]. The FDA has numerous options to use in seeking remedy against firms/individuals who violate cGMP regulations. Penalties can range from warnings to injunction, seizure, debarment, civil penalties (individual fines may reach up to $1,000,000), and criminal prosecution (fines/prison). More recent approaches by the FDA include hefty fines (intended to disgorge firms of any profit) and consent decrees. Best advice is to ensure you know you are in compliance and you have a method to monitor and track your systems and processes and ensure your firm is in and maintains a state of control to avoid the consequences of non-compliance.

AssurX is the recognized leader in the FDA-regulated life sciences industry with CATSWeb, a 21 CFR Part 11 compliant Quality and Regulatory Compliance Management solution, and is highly experienced in meeting the needs of this industry.

AssurX offers a multiple solutions and a flexible software delivery model (OnDemand and/or OnPremise) to both a large and small businesses in meeting these new FDA requirements for the vitamin and supplement industry. Among the many offerings are CATSWeb Pre-configured Solutions available for a variety of processes including, but not limited to:

• Complaint Management
• Supplier Management
• Document Control
• Corrective Action / Preventive Action (CAPA)
• Auditing

Further, by use of AssurX's OnDemand solution and expert Professional Services Organization, companies of any size can rapidly come up to speed with an efficient, cost-effective, and business-minded solution without the overhead and additional load to the IT department.

About AssurX, Inc.
AssurX, Inc., provides organizations with enterprise-wide global solutions for their quality management and compliance systems needs. With a choice of OnDemand services or OnPremise (licensed) software delivery options, AssurX offers CATSWeb – a flexible, comprehensive all-in-one solution that automates quality & regulatory compliance related processes so issues can be globally managed—from detection to corrective action to trend analysis. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise.

Click Here To Download:
•Product Sheet: CATSWeb Enterprise Quality Tracking System

Source: AssurX, Inc.