Supplier Qualification Guideline Touts Flexibility, Defers Best Practices

The Standardized Information on Dietary Ingredients Work Group publishes a guide to help supplement firms qualify ingredient suppliers under FDA good manufacturing practices. But with only three out of five major industry associations involved, not everyone is on board with the SIDI efforts.

A supplement industry coalition has issued a long-awaited pocket guide for qualifying ingredient suppliers – a major component of FDA’s good manufacturing practices regulation.

The Standardized Information on Dietary Ingredients Work Group, comprising three of the industry’s five major trade associations, opted to omit best practices from the draft guideline in a nod to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Manufacturing

US FDA’s Familiar Drug Pricing To-Do List

 

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

More from Compliance