New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm

Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is detailed in a free white paper available at http://www.microtestlabs.com/dietarypaper.

The white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008.

Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111.

“Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims. And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories.

“In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said.

For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on:

• Developing the Necessary Quality System
• Management “Buy In”
• Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
• Chemistry and Manufacturing Controls (CMC)

The white paper is available at: http://www.microtestlabs.com/dietarypaper.

“The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer.

“Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.”

For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper.

For more information, visit http://www.microtestlabs.com. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Building, Validating & Maintaining Controlled Environment Facilities is Focus of Oct. 18th Seminar in Boston Hosted by Microtest Laboratories

AGAWAM, Mass. — Building, validating, and maintaining a controlled environment facility is the subject of a daylong seminar on Oct. 18, 2011, hosted by Microtest Laboratories at the MIT Endicott House in Dedham, Massachusetts.

Titled “Keeping It Clean? The Building Blocks of Facility Control,” the seminar will focus on the clean room testing, disinfection validation, and related contamination testing issues that arise from manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

In each seminar program, industry experts will present practice advice and sound solutions in an interactive format that will encourage a high level of engagement by participants for questions, answers and discussion. The topics will include:

• Killing The Bugs Without Killing Yourself: Disinfectant Qualifications
• Feeling Like A Fish Out of WFI?: Water System Validation and Maintenance
• Got A Lot On Your Plate: Clean-room Validations and Maintenance
• The Old In & Out: Considerations On Insourcing vs. Outsourcing

“Keeping It Clean? The Building Blocks of Facility Control” will be presented 8:30 a.m. to 3:30 p.m. on Tuesday, Oct. 18, 2011, at the MIT Endicott House, 80 Haven Street in Dedham, Mass., just outside of Boston. Registration and a complimentary continental breakfast is at 8 a.m. Lunch will be served at Noon. The cost is $149 per person and includes meals, refreshments, and workshop handouts.

To register or for more information, visit the Microtest Laboratories website athttp://www.microtestlabs.com/seminar/index.asp. Or, contact Julie Adamski at 413-786-1680, toll-free at 1-800-631-1680, or at jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in controlled environment facility testing, laboratory testing, and contract manufacturing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Press contact: Don Goncalves, Tiziani Whitmyre, 1-781-793-9380, dgoncalves@tizinc.com