GMPs, QA & QC

FDA highlights GMP no-no’s

FDA highlights GMP no-no’s

By Shane Starling

The Food and Drug Administration’s commitment to greater transparency is bearing fruit in the dietary supplements area, with the availability of GMP 483 reports providing valuable insights into potential GMP pitfalls.

The devil in GMP details

DSHEA turns 15

The devil in GMP details

By Shane Starling

In the fifth and final installment of this DSHEA special, Frank Jaksch, the president and chief executive officer of Californian-based botanicals reference provider, Chromadex, outlines why he thinks current GMP inspection methodologies are unlikely to...

Blumenthal: On supplements regulations and outrunners

Special edition: DSHEA turns 15

Blumenthal: On supplements regulations and outrunners

By Shane Starling

In part two of this DSHEA special, Mark Blumenthal, founder and executive director of the American Botanical Council, outlines why he believes DSHEA is a victim of the “erroneous negative view” that it limits the power of the FDA and can’t control rogue...

DSHEA turns 15 and growing up fast

Special edition: DSHEA turns 15

DSHEA turns 15 and growing up fast

By Shane Starling

The Dietary Supplements and Health Education Act (DSHEA) celebrated its fifteenth birthday in October – a birthday some thought would not be achieved.

FDA cops (more) GMP criticism

FDA cops (more) GMP criticism

By Shane Starling

Insufficient inspection numbers, unclear ingredient identity testing and supplier audit requirements to meet Good Manufacturing Processes (GMPs), are some of the problems blighting the recently introduced regulation, says a Californian-based supplier.

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