CHPA supports the U.S. Food and Drug Administration's (FDA) federal regulations ensuring and enforcing product quality for over-the-counter (OTC) medicine and dietary supplement manufacturers.
CHPA member companies continuously monitor the quality and manufacturing processes of their OTC medicines and dietary supplements. Federal regulations issued by FDA provide the regulatory framework for ensuring product quality, starting with the ingredients in these products and continuing through manufacturing, distribution, and the product’s expiration date. Compliance with federal regulations is evaluated by FDA via regular manufacturing facility inspections. Individual states may also have laws and regulations that impact manufacturing and set standards for product quality. A number of organizations also provide guidelines or standards for ensuring product quality. Taking all these laws and regulations into consideration, a manufacturer develops internal standard operating procedures to document their processes and ensure consistently high-quality products are produced for the marketplace.
Herbs and spices have been part of commerce for thousands and thousands of years, and so have bad actors that substitute less expensive plant material for authentic plants. This practice known as botanical adulteration, has impacted the dietary supplement supply chain. But an industry initiative led by three leading nonprofits has developed a large scale program to reduce ingredient and product adulteration.
CHPA’s SVP of Dietary Supplements, Duffy MacKay, responds to reporting on a recent research letter published in JAMA finding that 22 out of 25 melatonin products analyzed were mislabeled, containing variable amounts of the ingredient:
If you are in the consumer healthcare industry, you probably know about GMPs, or Good Manufacturing Practices. But what do they specifically mean when it comes to dietary supplements, and how do VMS companies prepare for an FDA inspection?
Join Duffy MacKay, Senior Vice President of Dietary Supplements at CHPA, and George Paraskevakos, Executive Director of the International Probiotics Association to explore the science behind probiotics, why gut health is so important, and what’s next for this growing category.
CHPA supports efforts to harmonize the current Quality System Regulation with international quality management system requirements. However, CHPA recommends that FDA address several points of concern or clarification when finalizing the Proposed Rule.
This week CHPA filed an amicus brief urging the 9th Circuit U.S. Court of Appeals to confirm an appellate panel’s holding that a class in a class action lawsuit cannot be certified with more than a de minimis number of uninjured class members.
The Product Quality Research Institute (PQRI) is a non-profit consortium of that generates and shares timely, relevant, and impactful information to advance drug product quality and development. PQRI provides a unique forum to focus critical thinking, conduct research, exchange information, and propose methodology or guidance to pharmaceutical companies, regulators, and standard-setting organizations.