SUBSCRIBE

Breaking News on Supplements & Nutrition - North AmericaEU edition

News > Regulation

Read more breaking news

 

 
Loading...

Is finished product testing the next big wave in GMP warning letters?

By Stephen DANIELLS , 14-Nov-2012
Last updated on 14-Nov-2012 at 17:47 GMT2012-11-14T17:47:48Z

Is finished product testing the next big wave in GMP warning letters?

Once GMP inspectors from the FDA move beyond the first tier of GMP compliance, the next big wave of warning letters from the agency could be on the issue of finished product testing, says a leading quality and regulatory expert.

Aaron Secrist, Quality & Regulatory Manager for NOW Foods, told NutraIngredients-USA at the SupplySide West show in Las Vegas last week that, as the inspectors gain more experience and move beyond the first tier GMP compliance issues, they are going to start ask a whole new set of questions.

“Instead of, ‘Are you are doing finished product testing?’ the questions will be, ‘How are you testing? What are you testing? What are you not testing? What is your rationale for not testing?’” said Secrist.

We’ve already seen warning letters from the FDA this year for basic GMP non-compliance issues, and so is the industry ready for the next tier of inspections?

“I think some in the industry are more ready than others,” said Secrist. “I think one of the issues we face in this industry is a real lack of analytical methods and even some standards. Everything in analytical chemistry comes back to the standards.”

“Without the standards and methods in place, it is going to be very hard for the Agency to test these products and determine if they are meeting their finished products specifications.”

“The FDA needs to look at categories of products and start doing a lot of their own work to determine whether or not these products meet their specifications.

“It’s going to require a significant amount of development work on their end, since you don’t find these published in the literature.

“The other difficulty they are going to run into is that every company’s products are slightly different. The make-up of the product, the matrix, is different. Yes, they’re all multivitamins, but some have botanicals and some don’t, all of those things can make it very difficult for companies as well as the agency to test these products.”

Alkemist Labs CEO: We need transparency among the analytical labs

Alkemist Labs CEO: We need transparency among the analytical labs

The analytical community should embrace transparency to then allow manufacturers to share that with...

NOW Foods’ Secrist on the need for greater transparency and why brokers are ‘the bane of the industry’

NOW Foods’ Secrist on the need for greater transparency and why brokers are ‘the bane of the industry’

The recent NY AG probe has kick-started some industry organizations to say self-policing needs...

Qualitas says drawbacks of open pond algae cultivation easily dealt with

Qualitas says drawbacks of open pond algae cultivation easily dealt with

Qualitas Health, a supplier of a unique polar-lipid structured algal omega-3 ingredient, is now...

Mazza Innovation nears full scale production with innovative water extraction process

Mazza Innovation nears full scale production with innovative water extraction process

Mazza Innovation, a producer of botanical extracts, has moved beyond the proof of concept...

Cargill's Viatech platform deconstructs stevia leaf to identify better blends

Cargill's Viatech platform deconstructs stevia leaf to identify better blends

Cargill is “all in on stevia,” according to Scott Fabro, global business development director. ...

What opportunities are there in the NY AG botanical probe?

What opportunities are there in the NY AG botanical probe?

The New York Attorney General’s investigation into herbal supplements has been headline news for...

Newly available oilseed species features 'game changing' SDA content

Newly available oilseed species features 'game changing' SDA content

A new, more efficient form of plant-based omega-3s is coming to market in the...

Krill fishery offers opportunity to "get it right," sustainability expert says

Krill fishery offers opportunity to "get it right," sustainability expert says

The krill fishery offers a “last opportunity to get it right,” according to fisheries expert Dr...

Biased by industry? Do academic and business collaborations work?

Biased by industry? Do academic and business collaborations work?

Like many areas of nutrition research, probiotic and prebiotic science relies on strong collaboration...

Expert insights: What is the future for probiotics and prebiotics?

Expert insights: What is the future for probiotics and prebiotics?

Probiotics, prebiotics, and microbiome science are big business, and already generate a great deal...

African probiotic project reaching 10,000 infants a day

African probiotic project reaching 10,000 infants a day

Professor Gregor Reid

Chair , University of Western Ontario & Human Microbiology and...

UK researcher backs supplements for omega-3 intakes

UK researcher backs supplements for boosting omega-3 intakes

Philip Calder

Professor, University of Southamption

‘You think Red Bull’s just gonna roll over? It’s not gonna happen!’

‘You think Red Bull’s just gonna roll over? It’s not gonna happen!’ Expert warns wannabes

Beverage brand development guru James Tonkin has warned wannabe entrepreneurs that going up against...

Coffee may hydrate athletes just like water: Researcher

Coffee may hydrate athletes just like water: Researcher

Sophie Killer

Doctoral researcher, Loughborough University

Caffeine in small doses and during training may boost performance

Caffeine taken during training and even in small doses may boost sports performance: Researcher

Sophie Killer

Doctoral researcher in exercise metabolism and performance nutrition

Psychobiotics can feed gut-brain health axis: 'It’s really an exciting frontier,' says professor

Psychobiotics can feed gut-brain health axis: 'It’s really an exciting frontier,' says professor

Professor John Cryan

Chair and head of the Department of Anatomy and Neuroscience,...

Algatech: Functional food on astaxanthin horizon

Algatech: Functional food on astaxanthin horizon

Israeli firm Algatechnologies will work towards gaining approval for its astaxanthin as a novel...

Fed up: Probiotic research veteran issues global call to action

Fed up: Probiotic research veteran issues global call to action

Veteran probiotic researcher professor Gregor Reid is not a happy man. It’s time the...

Industry concerned about data abuse as EFSA fans transparency wings

Industry concerned about data abuse as EFSA fans transparency wings

Euros Jones

Director of regulatory affairs, European Crop Protection Association (ECPA)