Under Good Manufacturing Practices (GMPs, 21 CFR Part 111.75), manufacturers are responsible for qualifying their suppliers and the draft guideline offers recommendations as to how companies can ensure they are compliant in this regard.
Duffy MacKay, ND, chair of the executive committee, SIDI Work Group, and vice president, scientific and regulatory affairs, CRN, told NutraIngredients-USA: “We’ve developed a document that enables the industry to determine how qualified a supplier is.
“Industry needs to step up and self-regulate,” he added.
Industry stakeholders, regulators, and other interested parties have 60 days, ending June 18, to file comments with the working group, which will then assess submissions prior to finalizing the guidelines.
The SIDI working group is a coalition of dietary supplement trade associations, including the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA), as well as ingredient suppliers and dietary supplement manufacturers.
A number of leading industry voices, including the UNPA and the CRN, have been reinforcing the importance of complying with current good manufacturing practices (cGMPs), as the Food and Drug Administration increases its enforcement.
Only seven GMP inspections occurred in 2008, which increased to 34 in 2009, 84 in 2010. As of September 13 of 2011, there had been 145 inspections, according to FDA data.
The increase in inspections has been followed by a significant uptick in the number of warning letters for GMP violations: In 2010, FDA issued 8 letters regarding GMP violations. In 2011, that number quadrupled, with 34 companies being cited for a wide range of violations – from failure to establish product specifications to failure to maintain adequate records, according to Ivan Wasserman and La Toya Sutton from Manatt Phelps & Phillips in Washington, DC.
“In today’s complex global supply chain, proper component supplier qualification is essential for avoiding supply chain failures and maintaining traceability of products,” reads the guidance.
“There have been numerous public health crises in various FDA-regulated industries related to contamination or adulteration of material along the supply chain.
“This document serves as a voluntary guideline to assist manufacturers of dietary supplements (or other users of dietary supplement components) with compliance with the dietary supplement current good manufacturing practice (cGMP) requirements of the US Food and Drug Administration (FDA) 21 CFR Part 111.”
“The SIDI Work Group intends for the supplier qualification guideline to be flexible so that it can be applied across the industry, and so that large, medium and small companies will find it a useful tool to support the development of individual company supplier qualification programs,” said Dr MacKay.
“A practical aspect of the guideline is the stratification of supplier and component risk, which allows companies to better allocate limited resources during the supplier qualification process.”
The voluntary supplier qualification draft guideline accompanies earlier guidelines from the working group, including the SIDI Protocol and the CoA Guideline (Certificate of Analysis Guideline).
The Dietary Supplement Component Supplier Qualification Guideline outlines the process a dietary supplement manufacturer might use when qualifying an ingredient supplier.