The next rounds of GMP inspections from FDA will seek more raw data and expect that manufacturers demonstration continual operational improvements.

Developing a nutraceutical tablet means more than just considering the active ingredients and even excipients; understanding how the design of the tablet will impact production and delivery of the final product is critical to cost effective...

The variety of products and multiple layers of regulatory requirements makes compliance to FSMA a challenge for dietary supplement companies.

How do you know whether your contract manufacturer has the expertise to handle your dose delivery system?

The brand owner/contract manufacturer relationship can be advantageous for both parties as long as certain guidelines are followed.

Of all the rules outlined in the Food Safety Modernization Act (FSMA), food brands struggle the most with the foreign supplier verification programs (FSVPs) and hazard analysis and risk-based preventive controls (HARPC).

Supplement brands should consult peer-reviewed scientific studies to determine the amount of nutrients to include in products to ensure customers get the results they expect.

Contract manufacturers can help supplement brands ensure their products have efficacious doses by optimizing environmental and processing conditions during R&D and manufacturing.

Selecting a contract manufacturer requires a close evaluation of its supply chain management, given all the regulations that govern ingredient procurement.