Questions to help price match supplement manufacturers

Comparing Factories – Apples to Apples

 

We’ve found that on average, our prices are 10-30% less than what other GMP certified manufacturers offer. By GMP certified, we mean that they have the relevant GMP certification as a Manufacturing Facility (not a Warehouse Facility) from NSF (verifiable online on www.NSF.org) and a certification from UL.  We will match the price another factory quotes you should they be on the same quality level as our factory, see below, PRICE MATCH GUARANTEE.

Avoid GMP Certification Bluffing!

It’s dangerous to take a manufacturer’s word at face value. It’s not prudent, for example, to believe a PDF of GMP certifications from UL or NSF for two reasons:

A.   GMP certifications from NSF for operating a GMP warehouse, GMP distribution and a GMP manufacturing facility look THE same!

B.   GMP certifications frequently expire.

C.   The GMP certification may be for a different location.

A Warehouse in Manufacturer’s Clothing?

The only way to verify if the factory you are considering contracting with is certified as a manufacturer is to go to the UL and NSF websites, and in the case of NSF, look for the word “Manufacturing Facility” above the name of the company. 

For some reason, NSF displays the company name and address twice on the same page. You look for the following designations above the 2nd time they display the company name:

       Manufacturing Facility

·         Distribution Facility

·         Warehouses Facility

·         Packaging Facility

Ingredients Facility

 

 

Only the designation of Manufacturing Facility is acceptable for anyone you trust to manufacture your products

The NSF Certification for a Warehouse and Manufacturer Looks the Same! Many factories only have a warehouse certification from NSF.

 Many factories misleadingly display the NSF icon on their websites as they advertise that they are certified as a supplement manufacturing facility, when in fact they are not.

 

 

If a factory does not have a GMP Manufacturing Facility certification from NSF, it means they are not inspected the same way. Raw material testing, in process testing, blend stage testing and finished goods testing are not audited! Having a clean warehouse facility is important, however, it’s more important to have a verified, audited, and certified GMP system in the manufacturing facility itself.

v  Your raw material may not be tested for purity, potency and most importantly identity.

Ø  It’s common for factories to skip the ID testing for botanicals.

Ø  Those ID tests can only be performed using HPTLC, so ask upfront!

v  Your overages may not be correctly calculated or monitored.

Ø  Your competition can easily find out if you meet label claims.

v  Your in-process tests may be omitted.

v  Your finished goods testing protocols may be ignored.

Ø  FDA’s most frequent Warning Letters, called “Form 483” are about failure to perform finished goods testing.

v  The facility may not have a BSL-2 microbiology lab.

 

The lack of GMP Manufacturing Facility certification can result in adulterated products that don’t meet label claims or worse, contaminated products that need to be recalled. It is therefore important to NOT rely on a PDF of a GMP certification from NSF. The only way to verify a manufacturer is to look them up on the NSF website. You can look us up here:

We emphasize quality because we know our company lives and dies by quality.

 

The 3 Risk Eliminators!

Eliminate the following 3 risks by hiring a properly certified GMP factory. 

 

Eliminate Risk 1: Rejection by Amazon.

Amazon is currently aware of the difference between the different GMP designations and how to check for them.


Amazon states: For each dietary supplement product or ASIN, you must submit the following documents:

A valid good manufacturing practice (GMP) certificate issued by an accredited third-party certification body in compliance with 21 CFR 111 (for products that are a dietary supplement as defined at 21 U.S.C. 321(ff)), or 21 CFR Part 117 (for any other human food product as defined at 21 U.S.C. 321(f)), or both. Amazon accepts GMP certificates from accredited third-party certification bodies, including NSF/ANSI 455-2, NSF/ANSI 173 Section 8, GRMA 455-2, UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

 

Risk Eliminator 2: Not Meeting Label Claims and Having Too Much Lead in the Product.

Once you are on the platform of choice you want to stay there! You don’t want your competition to be able to kick you out of there! If your actual potency does not meet label claims, then you become vulnerable. If your label is not per regulation, you are also at risk. If your product contains too much lead, you run afoul of California Proposition 65, which can issue civil penalties of up to $2,500 per day for each bottle. It’s a racket, but it’s real, and you need to know what you are doing.

 

Risk Eliminator 3: Failing To Benefit Your Clients

 

The best way to build your brand is to sell products that actually work. You can do that by ensuring that the herbal extracts used in your products are what the supplier says they are – in other words, they are not “fake ingredients” or what are called adulterated ingredients. 

 

We have found that over 30% of all herbal powders and extracts we receive are in fact adulterated. 

This is why we check 100% of all incoming herbal extracts and powders for IDENTITY, and in the process, we have been able to identify what’s wrong with the supply chain.

 

 

  1. Wrong plant parts found in powder

  2. Wrong species

  3. Herbal powder is already extracted

 

The only way to check for IDENTITY of herbal ingredients is with high-performance thin-layer chromatography (HPTLC). You most definitely should ask your manufacturer if they have this analytical instrument in-house. Don’t be fooled. It’s not possible to perform identity checks with HPLC (high-performance liquid chromatography) or FTIR, and DNA is useless on extracts and powders because the DNA has been damaged.

 

 

Price Match!
Invest 5 minutes of your time and copy and paste the below questions to the manufacturers you are considering working with:


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  1. CERTIFICATIONS:
    Is your factory GMP certified with NSF and UL?
    For how many years?

Can you please send me the link on www.NSF.org – showing your factory is NSF certified as a Manufacturing Facility?

  1. LABORATORY:
    Do you operate an internal laboratory with the following instruments?
    Have you operated the lab for at least 3 years?
    The more years of experience the better because expertise is built over time. At the very least you need them to have 3 years experience. PureNSM has operated a lab since 2011. The equipment we operate is as follows:

    1. HPTLC – High-performance thin-layer chromatography
      (Number of methods developed, PureNSM has over 250 methods developed)

    2. HPLC – High-performance liquid chromatography

    3. FTIR – Fourier-transform infrared spectroscopy

    4. ICP-MS – Inductively coupled plasma mass spectrometry 

    5. BLS2 Microbiology Laboratory 

    6. Rapid Microbiology Systems from Solaris and 3M

Can you supply the following photographs?

  1. Overview and close-up pictures of all equipment in the laboratory

  2. Detailed pictures of the validation stickers for each instrument

  1. QUESTIONS ABOUT IDENTITY TESTING OF RAW MATERIALS
    Do you test 100% of all incoming herbal raw materials on your in-house high-performance thin-layer chromatography (HPTLC) systems?
    Do you test chemicals, vitamins, aminos on FTIR?

  2. QUESTIONS ABOUT MICROBIOLOGY TESTING:
    Do you operate a rapid Microbiology Systems (for example from Solaris) on-site?
    Do you operate a BLS 2 Microbiology lab on-site, or do you plan to do so?

  3. QUESTIONS ABOUT HEAVY METAL TESTING:
    Do you calculate the arsenic, cadmium, lead, mercury level in each product run?
    Do you notify clients if the product does not meet Proposition 65 limits?

  4. POTENCY TESTING and OVERAGES:
    Do you perform finished goods potency tests? Please describe your finished goods potency procedure and how you ensure my products will meet label claims, including your plans for adding overages in my products. Please list all my ingredients and tell me how much overage you will add for each ingredient.

  5. DEGRADATION TEST FOR EXPIRATION DATE VALIDATION:
    Will you help me validate my 2-year expiration date? Will you help me gain a 3-year expiration date if appropriate, overtime?

  6. QUESTIONS ABOUT QA/QC:
    Are there two separate QA and QC departments in the factory?

How many people work in each department?

Can you provide the QA/QC flow charts?

 

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A Deeper Look Into Those Questions
Let’s dig deeper and find out why we recommend you ask those questions.

 

  1. CERTIFICATION:
    Is your factory GMP certified with NSF and UL?
    For how many years? 

The more years the better, 3 years minimum. Why 3 years? NSF and UL are very forgiving with manufacturers the first couple of years, and then they rack up the requirements.


Here you have to be very detailed in order to avoid a very common GMP Bluff!


Do not request or accept a PDF of a GMP certification!
As of August 2022, NSF issued the same GMP certification for warehouses, distribution facilities and manufacturing facilities. This has resulted in many companies certified GMP as a warehouse facility to CLAIM they are certified as manufacturers.

 

The only way to avoid being taken advantage of is to search the NSF.org website for the name of the manufacturer and look for the words “Manufacturing Facility” above the name and correct address (matching pick up address) of the factory. If you see them listed as “Warehouse Facility” or “Distribution Facility” then you know they are bluffing you. 

 

Another reason not to rely on PDFs of GMP certifications is that they frequently expire because of noncompliance. Lastly, all certifications have an expiration date, check it!

 

You can look up PureNSM certifications here:

PureNSM GMP certification from NSF is HERE.

PureNSM received NSF certification in 2014 and is currently registered. Search for us under Manufacturer Name Nutritional Supplement Manufacturers. You will see us listed as follows:

Manufacturing Facility

Nutritional Supplement Manufacturers, Inc.

1055 Bay Boulevard Suite D Chula Vista, CA 91911


PureNSM GMP certification from UL is HERE.

Click Ctrl+F and search for PureNSM or Nutritional Supplement Manufacturers.

PureNSM received UL certification in 2017 and has renewed every year since. 

 

PureNSM GMP certification from NPA is HERE.
Click Ctrl+F and search for Nutritional Supplement Manufacturers or PureNSM.

PRICE MATCH! We price match with competing contract manufacturers once we see their link to NSF listed as Manufacturers. We also require their link to UL showing them listed as UL Certified GMP Manufacturers.

  1. LABORATORY:
    Do you operate an internal laboratory with the following instruments?
    Have you operated the lab for at least 3 years?
    The more years of experience the better because expertise is built over time. At the very least you need them to have 3 year experience. PureNSM has operated a lab since 2011. The equipment we operate is as follows:

  1. HPTLC – High-performance thin-layer chromatography
    (Number of methods developed, PureNSM has over 250 methods developed)

  2. HPLC – High-performance liquid chromatography

  3. FTIR – Fourier-transform infrared spectroscopy

  4. ICP-MS – Inductively coupled plasma mass spectrometry

  5. BLS2 Microbiology Laboratory 

  6. Rapid Microbiology Systems from Solaris and 3M

 

Can you FaceTime with me as we take a tour of your laboratory and factory?

At the very least, can you supply the following photographs?

  • Overview and close-up pictures of all equipment in the laboratory

  • Detailed pictures of the validation stickers for each instrument

 

Having the equipment is one thing while calibrating and using it is another. Therefore, it is very important to ask how many years they have operated the equipment and how many people work in the laboratory.

Further, ask for up-close pictures of all lab equipment and the validation stickers for each machine.


PRICE MATCH! We price match if you can forward an email with a statement from the manufacturer describing their in-house laboratory, roughly matching the above.

  1. QUESTIONS ABOUT IDENTITY TESTING OF RAW MATERIALS
    Do you test 100% of all incoming herbal raw materials on your in-house high-performance thin-layer chromatography (HPTLC) systems?
    Do you test chemicals, vitamins, aminos on FTIR?
    You are looking for 3 years experience minimum. PureNSM has over 7 years experience as of 2022.

    PRICE MATCH! We price match if you can forward an email with a statement from the manufacturer describing their experience in running their own HPTLC.

  2. QUESTIONS ABOUT MICROBIOLOGY TESTING:
    Do you operate a rapid Microbiology Systems (for example from Solaris) on-site?
    Do you operate a BLS 2 Microbiology lab on-site, or do you plan to do so?

    Raw materials must be tested for microbiology growth before safely entering the factory. We highly recommend finding a GMP audited factory with laboratory instruments actively used and calibrated. Delays will occur if these instruments aren’t available on-site!


PRICE MATCH! We price match if you can forward an email with a statement from the manufacturer describing their Microbiology testing protocols, analytical equipment, etc.

  1. QUESTIONS ABOUT HEAVY METAL TESTING:
    Do you calculate the arsenic, cadmium, lead, mercury level in each product run?
    Do you notify clients if the product does not meet Prop 65 limits?

    PRICE MATCH! We price match if you can forward an email with a statement from the manufacturer describing their experience in running their own ICP-MS.

 

  1. POTENCY TESTING and OVERAGES:
    Do you perform finished goods potency tests? Please describe your finished goods potency procedure and how you ensure my products will meet label claims, including your plans for adding overages in my products. Please list all my ingredients and tell me how much overages you will add for each ingredient.

(You are looking for a non-defensive answer. The manufacturer needs to understand you care about meeting label claims because, well, this is YOUR product. You will want to have transparency on this issue. An acceptable answer is that they provide you with an initial overage plan, showing ingredients with high overages (over 10%). Every single ingredient needs an overage, ingredients with potency claims may need up to 50% overage.)

PRICE MATCH! We price match if you can forward an email with a statement from the manufacturer describing their proposed finished goods testing protocols for your products.

  1. DEGRADATION TEST FOR EXPIRATION DATE VALIDATION:
    Will you help me validate my 2-year expiration date? Will you help me gain a 3-year expiration date if appropriate, overtime?
    (You are looking for cooperation in performing either an accelerated test or real-time test.)

 

  1. QUESTIONS ABOUT QA/QC:
    Are there two separate QA and QC departments in the factory?

Can you provide the QA/QC flow charts?
(You are looking for 3 people minimum per department because that is the absolute minimum to run the basic GMP protocols. PureNSM has 12 employees total as of 2022 in QA/QC.)

PRICE MATCH! We price match if you can forward an email with a statement from the manufacturer describing their QA/QC staff and process, roughly matching the above.

I hope you found this exercise useful. Validating your manufacturer may save you from being de-platformed or your brand being recalled. Over 800 supplements were recalled in 2020 by one contract facility that offered great prices but lacked quality control.

PRICE MATCH!

We don’t negotiate against hearsay so we request that you email us the chain of emails from first contact to where you are today. This should include a quote and answers to our questions above. If it looks credible, we will match them!

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We emphasize quality because we know our company lives and dies by quality.