Top 14 Questions to Ask Supplement Manufacturers, BEFORE YOU HIRE THEM

Top 10 Questions to Ask Supplement Manufacturers

If you’re a marketer of nutritional supplements, the most important single question to ask yourself is “What product should I put on the market?” But once that’s been answered, the second most important question is, “Who should manufacture that product?” The right choice can make the difference between a market leader or an average product, between an easy process or a painful one, between success and failure.

good answers

The answers to these questions should make decision-making easier and yield the best conclusion. No one good answer will be a dealmaker, but a majority of good answers will give you a significant advantage.

Times Have Changed.

Times Have Changed

Some two decades ago people could make supplements in their garages. Times are different now; especially post new GMP regulations and FDA increased enforcements. There are a lot of hurdles to overcome to comply with GMP regulations. But make no mistake about it, some US manufactures behave like they are still in their garages. This is why it is so important to make sure you select your contract manufacturer carefully.

We suggest you ask them the following questions:

1. What certifications do you have?

certifications for manufacturer

It’s not what the company says about itself that’s important; it’s what others say about them when it comes to (a) Quality and (b) Financial Integrity.

(a) Judgment of quality is more easily determined by checking if the manufacturer belongs to one of the following four GMP (good manufacturing practice) certifying organizations:

          a. NPA Certification by Natural Products Association – www.NPAinfo.org
          b. USP Certification by United States Pharmacopeia – www.USP.org
          c. Pharmaceutical Consulting Services – www.Comply2000.com

The above 3 organizations offer certifications for contract manufacturers of dietary supplements. The judgments of these organizations are completely objective and offer a seal of approval.

The Current Good Manufacturing Practices (CGMP) regulations are relatively new and not all manufacturers are following those practices. (For more information the regulation is described in 21 CFR 111.75 which can be found at: http://www.fda.gov).

(b) Financial Integrity is best judged by other organizations that certify financial health of the company. One such organization is Dun & Bradstreet (D&B). You should ask any company you want to deal with in USA for their D&B number and then check if they are in good standing.

2. How long have you been in business?

How long have you been in business

The longer a company has been manufacturing pure supplements without excipients, the more it has been able to learn.
experience
Does your manufacturer have the expertise, skill and culture to manufacture pure supplements? Or are they just picking up on the trend now because it’s a popular? Knowing the answer to this question can save you headaches down the road.

3. Do you actually manufacture?

Do you actually manufacture

This may sound like a silly question but we get this question all the time. Many of the largest contract manufacturing companies in USA actually contracts over 95% of their manufacturing out to other companies. This causes longer lead time but most importantly loss of control.

The worst thing is if you are buying from a “manufacturer” that does not manufacture their own products; he may not know exactly what’s in the supplements. Contract manufacturers often don’t disclose accurate information about ingredients (even if required to by FDA) and will even substitute “similar” ingredients into the mix if they run out of a particular raw material – without telling anyone! There is no telling what is in the supplements!

In a recent study by the University of Guelph in Canada published in the BMC Medicine journal they found 60% of the herbal products contained plant species not listed on the label and 32% of the products had substitutions. This is important to be aware of if pure supplements are important to you.

4. Do you only use Pure Form of ingredients in My Product?

Trust me

It is a common misnomer that if you take a certain mg amount of a supplement that it does not matter in what form it is, how it is packaged and with what it’s packaged. Take Vitamin C for example. You can get it in many forms and some are more absorbent than others. Even if you see “Ascorbic Acid” on the label of two different products, the ingredients can vary. One manufacturer may use 90% Ascorbic Acid with 10% Corn Starch and Lactose (for better handling in manufacturing). Of course, a manufacturer that focuses on purity will use 100% Pure Ascorbic Acid. Unfortunately, this is true for lots of ingredients, including the following:

Our Raw Materials

Other Manufacturers’ Raw Materials

How it’s reported in the supplement facts box

Pure Ascorbic Acid

90% Ascorbic Acid, with 10% Corn Starch and Lactose

Vitamin C

Pure Vitamin D

0.1% Vitamin D dilution in a base of Dicalcium Phosphate, Lactose, Acacia, BHT, Sodium Benzoate, and Sorbic Acid

Vitamin D

Pure Riboflavin

33% Riboflavin, with Mono- and Diglycerides of Fatty Acids surrounding each particle for better flow, flavor and masking

Vitamin B2 (as Riboflavin) mixed with rice flour for a uniform blend

Pure Vitamin B12 as Cyanocobalamin

Cyanocobalamin (0.1% B-12 dilution in a base of Corn Starch with Sodium Benzoate and Sorbic Acid)

Vitamin B12 (as Cyanocobalamin) mixed with rice flour for a uniform blend

Pure Biotin

1% Biotin diluted on a base of Dicalcium Phosphate, Lactose, Sodium Benzoate, and Sorbic Acid

Biotin

Pure, Undiluted Pepsin

Pepsin, standardized with Lactose

Pepsin

Pure, Undiluted Pancreatin

Pancreatin, standardized with Lactose

Pancreatin

Pure, Undiluted Bromelain

Bromelain, standardized with Lactose

Bromelain

Pure, Undiluted Papain

Papain, standardized with Lactose

Papain

5. What kinds of testing do you perform?

What kinds of testing do you perform

It is a good sign if the company has its own in-house lab. It means that they take quality control seriously.

Raw materials have to be tested EVERY TIME in accordance with cGMP regulations. Outsourcing all lab tests is prohibitively expensive. Therefore it is a clear sign of poor quality if the manufacturer does not have an in-house lab – and it’s not enough to ask!

If you simply ask the manufacturer if they have an in-house lab, he will say yes we do. That’s not enough; you need to ask them for a list of equipment they operate in the lab.

It is common that the “in-house lab” only consists of a coliform stick. This is unacceptable. Also make sure they are actually using the lab they show you. Ask to talk to the lab director or the person who will be conducting the tests on your products. Here are questions to the in-house lab. (Make sure your account representative does NOT answer those questions).

Question 1: Who will test my product?

Question 2: What equipment will you use when testing for:
1) Identity (example of a good answer: FTIR, HPLC)
2) Heavy metals (example of a good answer: ICP)
3) Microbiology (example of a good answer: automated Biolumix equipment and 3M)
Note: if they only have 3M system they can’t test for all that is required.

Question 3: Can I visit your lab while you are there and can you then show me what you are currently testing? Can you give me a tour of your quarantine system? Can I review your test results that are attached to the production records?

6. Does the company follow the cGMP SOPs? Show me an example please…

company follow the cGMP SOPs

The caliber of a company’s staff is one measure of the quality of the products it manufactures. The level of experience, education and training are good predictors of quality. Is there an ongoing refresher training program in place for personnel to ensure adherence to standard operating procedures (SOPs)? Obviously, the greater the amount of experience, education and training the staff possesses, the more likely the contract manufacturing experience will be a positive one.

Talk is cheap. Action is golden. The kind of company you want to work with should painstakingly follow all SOPs. Ask to be taken on a tour around the facility and then when you see some production workers taking powder or capsules from a container, do a quick inspection. Check if the container has three stickers on it. All raw materials should have:

• Quarantine Sticker
• Testing Sticker
• Release Sticker

Ask your contract manufacturer to show you examples of Production Records that have been filled out by their staff.

7. Can you handle complex liquid formulations?

Can you handle complex liquid formulations?

Manufacturing complicated liquid formulas is probably the most demanding task a manufacturer can take on. If a product demands a high degree of precision and the contract manufacturer doesn’t have relevant experience, it’s a major gamble. Liquid formulations can easily become contaminated if mistakes are made in formulation or manufacturing.

Your brand is the most valuable asset you have. The best way to protect it is to choose the best company to produce it.

8. What is the company’s communication style, will it work for you?

company’s communication style

Don’t get hooked on a contract manufacturer if they don’t communicate with integrity and not on time, let alone if they lie to you about what they put in your product! It isn’t unheard of. When some contract manufacturers run out of one ingredient, they simply replace it with another! WITHOUT TELLING YOU! This means your product can cause harm! Your label is incorrect! Your product becomes liable to confiscation by FDA. You don’t want that!

If the company does not inform you of production schedules upfront then don’t work with them. Of course they will not hesitate to sign an NDI. But more importantly, because NDI is just a piece of paper, do you trust that the heads of the company won’t “give” your formula to others? The last thing you want is your formula being used in competing products!

9. Do you have experience with Prop 65?

Warning from California Republic

You don’t want to get caught in this trap by working with a company that doesn’t know the proper testing to comply withCalifornia’s Proposition 65. If they don’t have an ICP then they can’t test your product in-house. Are they able to calculate and inform you about the proper dosage allowed for your formulation?

10. Will they give you guidance on label regulations?

guidance on label regulations
An experienced contract manufacturer can help you with your label, although the ultimate responsibility of the label rests in your hands, and no one will have studied it more than you.

Ask them if they think your “Structure and Function” claim is up to par. What documentation do you need to have handy to substantiate your claim? Is your supplement box correct?

supplement Facts

11. Will they try as hard as possible to avoid unnecessary excipients and lubricants?

avoid unnecessary excipients and lubricants
If you don’t want those things in your product you shouldn’t be forced to accept it. Here is a list of additives you may want to be without. Whatever your opinion is on this issue, it makes good marketing sense to avoid anything that may be objectionable to the consumer, such as:

Magnesium Stearate
Titanium / Silicon Dioxide
Cellulose, Silica, Stearic acid and much more…

As reported by Natural Foods Merchandiser: “Consumers want clean labels with words they recognize, and the fewer ingredients the better.” You need all the help you can get to market your products. Don’t let your contract manufacturer convince you that you “NEED” to put one of those nasty things in your products.

Customers don’t want ingredients they don’t know or recognize, such as magnesium stearate, titanium / silicon dioxide, cellulose, silica, stearic acid, colors, methyl paraben, propyl paraben and so forth. Rather have them change the formulation and use only flow agents that are less controversial such as organic rice flour.

The avoidance of hard to understand and possibly toxic manufacturing agents is a definite trend that has taken years to form and will not go away.

12. Do they Clean with Toxic Chemicals?

Clean with Toxic Chemicals

If you want to minimize the possibility to getting complaints fromhypo allergenic customers then ensure your manufacturer does not clean with potential allergens.

Chemicals

Many companies use laundry bleach like CHLOROX, this is obviously a bad idea because it often contains extra chemicals, for example“bluing agents”made from dies that many say can cause big problems when trace amounts are ingested.Most brands of Clorox are not certified safe for food but are available in every store so many companies use it instead of NSF grade food safe bleach.

“Simple” Green contains: Tetrasodium N,N-bis(carboxymethyl)-L-glutamate, Sodium carbonate, Citric Acid, Colorant (GREEN), Fragrance. Simple enough but if trace amounts of those chemicals get into the supplements can they cause allergic reactions in a chemically sensitive person?

We recommend you only clean with edible cleaning solvents. We at Pure NSM use two cleaning solutions we make ourselves: “Black Death” made from iodine and grain alcohol and “White Death” made from ammonia and gain alcohol. In case you are wondering… Ammonia is used in many foods, for example cheese and cookies.

13. Will they drop ship the products for you?

drop ship the products for you

If you ever want them to ship directly to your customers, make sure they can do this for you. The fact is that FedEx, UPS and others do not allow “fulfillment companies” to charge low shipping rates. Only if the company sold you the products can they charge you the low rates. The carriers do that in order to protect themselves.

As an example, if you take your product to a fulfillment house they will have to charge you $5 whereas if you have your manufacturer send the product they can do so for $3. The savings add up.

How dropshipping work

14. Does the manufacturer operate on ERP system?

manufacturer operate on ERP system

If formulation, inventory and production records are kept on Excel spreadsheets it can cause disorganization, confusion, mistakes and will make it easier for the employees of the manufacturer to cut corners without leaving a trace.

Therefore always ask if the company operates on Enterprise Resource Planning (ERP) software. There are ERP systems available that comply strictly with the FDA’s 21 CFR Part 11 and cGMP standards, including electronic signatures and audit trails. Warehouse and Shipper information fully complies with the Bioterrorism Act.

If a contract manufacturer has not invested in such a system where else could they be cutting corners to save money?

No Flow Agent

Top Notch Purity


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