In Response: Dietary Supplement Quality Professional Training

The dietary supplement industry has been under increased regulatory and consumer scrutiny over the past several years. Many feel that the industry is under-regulated as compared to the food and pharmaceutical industries. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers are not required to register products with FDA. Rather, the dietary supplement manufacturer must ensure that a dietary supplement is safe before marketing it and that the product label information is truthful and not misleading. The main exception is for products introducing a new dietary ingredient, in which case premarket review for safety data and other information is required. As of June 2010, federal regulations also require all manufacturers to follow Good Manufacturing Practices (GMPs), which includes conducting ingredient testing on all incoming raw materials and finished-product testing for all outgoing lots of product.

With the increase in regulatory requirements-and the industry still determining best industry practices-it can be overwhelming to build a robust and practical compliant quality system in your facility. A new training program consisting of a series of comprehensive modules provides a tool for quality managers and personnel whose job function is to manage or assist in the implementation of a quality system. The Dietary Supplement Quality Professional (DSQP) training program provides dietary supplement quality and technical professionals with the expertise and best practices to deliver safer, higher-quality, reliable products.

The DSQP training is designed for quality leaders and technical professionals from quality, manufacturing, engineering, regulatory affairs, and research and development. The training offers participants technical, scientific, and regulatory knowledge, as well as the skills and confidence to add significant value to their organizations.

The DSQP training is a three-way partnership between:

• NSF-DBA, an NSF International organization with more than 25 years of experience providing consulting, training, and auditing services to the dietary supplement and pharmaceutical industries

• Industry trade association United Natural Products Alliance (UNPA)

• The National Center for Natural Products Research (NCNPR) at the University of Mississippi

The extensive industry experience of NSF-DBA instructors helps provide tangible, real-world case studies of workplace situations and one-on-one interaction. NSF-DBA trains health science professionals about regulatory compliance through GMPs, as well as Human Error and Qualified Person and Quality Professional classes.

Based on the requirements set forth in the current GMPs in manufacturing, packaging, labeling, or holding operations for dietary supplements (21 CFR 111), the DSQP training consists of 12 modules. They are designed to provide the knowledge and skills expected of today’s dietary supplement quality and technical professionals, giving them the confidence to implement quality systems and build a culture of quality within their organization. More than 100 professionals have already participated in the DSQP training courses.

Each module consists of a mix of lectures and group exercises, maximizing the learning for the participants. The module series includes:

• 21 CFR 111-GMP overview

• Standard operating procedures and recordkeeping for compliance with 21 CFR 111

• FDA inspection readiness

• CAPA (Corrective Action) management

• Testing method selection, specification setting, and equipment qualification

• Stability program development

• Vendor qualification and audit training

• Cleaning, controlling cross contamination

• Process definition and control; facility/utilities design and monitoring

• Risk assessment and risk management

• Staff recruitment and internal training development

• International regulatory requirements for dietary supplements

Courses are offered by UNPA in Salt Lake City, UT; NSF-DBA in Ann Arbor, MI; NCNPR in Oxford, MS; and in conjunction with industry events. Courses will also be offered in 2012 at venues located in California, Florida, Salt Lake City, and on the East Coast.

For more information, visit www.nsf-dba.com or contact NSF business development manager Dave Trosin at ds@nsf-dba.com or at 734/827-6856.