How to Verify a Contract Manufacturer
At one time, someone with a great idea and a lot of ambition could create a dietary supplement in his basement and bring it to market without much trouble.
He might even get rich and become a major player in the industry.
Some people certainly did. Since then, the FDA and other regulatory bodies have raised the bar for standards of quality so that not just anyone can turn out a legally viable product.
CHECK: SAMPLE CONTRACT MANUFACTURING AGREEMENT
But there’s still good news. Dietary supplement contract manufacturing has come along and bridged the gap.
Verifying a Contract Manufacturer’s Reputation
The dietary supplement contract manufacturing industry is a small world. Reputation is critical in this business.
So you should not be afraid to shop around, and ask questions. You should establish that the CM you are considering partnering with does not substitute ingredients in the manufacturing of your product.
This could easily lower the quality of your product.
Compare Price Points
Practically all industry experts agree that you will get the product that you pay for.
Suppose, for example, we are charged $5 per unit and someone says they can get it for $2.
You can bet that manufacturer is cutting corners somehow by using cheap ingredients or skimping on the amount of any given ingredient.
This leads us to testing. Testing proficiency is essential. Old certificates of analysis (CA) are outdated.
In the past, an ingredient would come in, and the CA said it was white when everyone could see it was brown.
So when you look into a CM, find out who is testing the ingredient.
These tests require knowledge and experience. That means testing must be being done by a qualified and experienced professional.
A company should do regular audits of their CM.
Examine the batch records, raw-material certificates of analysis, and ensure all the requisite testing is being done.
If a price quote looks too good to be true, it goes without saying that it probably is.
The most influential suppliers offer things like price match and reward point systems.
Look for Past Recalls
No one wants to get hit with a recall. Recalls are extremely costly and damage a company’s reputation.
But if a recall has happened, there will be a great deal of paperwork left behind.
When you are considering partnering with a CM, check for past recalls.
Keep in mind that just because a recall happened, does not mean the CM is not worth doing business with.
But you should look into the reasons behind the recall to learn the circumstances that created it. That way you can make an informed decision based on the production practices of that CM.
Look for Proactive Partners
A CM should pay attention to detail, keeping up with regulation and enforcement changes.
Every CM should read the FDA’s warning letters for a start to help their clients avoid problems.
In order to anticipate the needs of their customers, a CM must be proactive.
Technologies are constantly changing, providing new opportunities to diversify product lines.
But, they also necessitate staff training and sometimes buying new equipment is also necessary.
Contract manufacturers must advise their customers on the implications of new regulations as they arise.
CMs can also offer suggestions and advice about trends and ways to ease manufacture.
There is great potential for variation within existing formulas.
A proactive CM will often take it is their responsibility to inform their customers when they see potential issues with a formula.
One of the ways in which reputable CMs can be effective is through individualized account management.
This means clients will be assigned a product advisor through the whole process, thereby eliminating any confusion.
COPING WITH RAISED COSTS OF INNOVATION
Higher standards imposed by regulating agencies are having an effect on the cost of product innovation.
Earlier this decade, the FDA started cracking down on smaller companies that were unable to meet GMP requirements. Since then, there has been a bit of a slowdown in the speed of new products being developed.
This has caused brand managers to consider outsourcing to companies overseas, but that proposition comes with some risk.
When done legally, it’s very expensive, creates a lot of paperwork, and the certification standards are especially high.
After spending thousands upon thousands of dollars, the last thing a brand owner wants is to hear is that the product is being confiscated of destroyed by customs because it doesn’t have the all the required documentation.
For these reasons, it’s usually better to partner with a domestic manufacturer.
Experienced dietary supplement contract manufacturers report that the most common snags they run into with brand managers looking to bring new products to market are a lack of knowledge about GMP requirements and misconceptions about how long it takes to manufacture a dietary supplement product.
This means that partnering with a proactive and reputable contract manufacturer is an indispensable part of any formula for success. And that’s a fact that you can take to the bank.