Useful Articles - Health and Fitness

Why GMP Should Matter To You

I must warn you of something very dangerous that is a plague on the supplement industry. It's called NO STANDARDS. Did you know that unless a compa

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ny uses GMP certified manufacturing, you have no way of knowing the quality and amount of the ingredients in your supplement?

Think I am bsing on how wide spread this is? Think

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

of a really good protein bar that hit the market in the last 4 years. Notice that they probably don't taste like that any more? I can think of three examples off the top of my

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

head (not naming names of course). One was a rich gooey peanut filled bar that hit the market like a monsoon! Ever have one now (3 years later)? You get a hard, dry piece of

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

crap that tastes like garbage. How about my favorite caramel apple bar? Yum they were good with dripping pieces of caramel and nice chunks of apple. I had one the other day an

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

d oddly enough there was no caramel, hard apple chips and the bar was a rock. So, without taking down the supplement industry and opening my self up to lawsuits, you the consum

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

r, need to really insist on a new standard for supplements, one that ensures you get what you pay for. The government (about one of the few things they are doing right) is abou

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

t to issue mandatory GMP certification for dietary supplements, but that is still 1-3 years off, so I HIGHLY suggest you buy ONLY GMP certified today.

GMP is a government stand

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

rd that assures quality and accuracy in your supplements. A word to the wise, buy ONLY GMP certified supplements, since if you don't there is no way to know what you are putti

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ng into your body. Trustonly people that use GMP certified labs to produce its supplement line, so you can believe that the product contains EXACTLY what is on the lab

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

l.

If you buy some off brand "bargain" supplement, you could be getting saw dust for all you know, and you have not only wasted time but money too! Look for GMP cert

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ification (on the bottle) for all of your supplements and nutritional needs. Don't think it doesn't happen. There are whole web sites designed to expose supplement compani

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

s who do not meet label claims and some of your most popular brands can test out to contain none of the ingredients that you THINK are in the bottle. Trust only the government

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

GMP certification to ensure quality.

Think it doesn't happen? This stuff happens! Just look at the recent issues with pet food. If you didn't follow it, pet food made with C

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

inese protein was killing innocent pets. The manufacturers had no idea why until they tested some brands and found that the protein was "contaminated" with something that made

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

it weigh more yet hurt the pets. Why would Chinese manufacturers do this? Well, if the additive weighs more in the same volume, they can charge the same for including less pro

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ein in their shipment. This stuff happens and the only remedy is GMP certification. I STRONGLY encourage you to look for a GMP logo on every supplement you purchase. If not,

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

you may at best be throwing your money down the drain or at worst putting something harmful into your body!

Ok, I am off my soap box for a bit, but it ticks me off that quality

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

companies spend lots of money to make sure their products work, only to get knocked off by people that use low grade manufacturing which is not GMP certified and can contain pot

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

entially half the ingredients listed on the bottle. We all pay a lot for our supplements, and I expect that companies would want GMP certification. Ask yourself why they don't

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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