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Supplier Qualification Guideline Touts Flexibility, Defers Best Practices

 
• By Dan Schiff

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...

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More from Manufacturing

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

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.

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