Nutraceutical Knowledge

How to get a GMP Certificate

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With the increasing number of new supplement manufacturers, the increasing demands for quality become even more apparent as competition stiffens in one of the fastest growing industries worldwide.

And more companies mean that even more products flood the market, so logically this calls for tighter regulations and control that have to be implemented by none other than the FDA.

Thus, having a GMP certificate is indispensable for your company, in order to conform to the guidelines set by the agencies that control the manufacture processes of not only supplements but also certain foods, pharmaceuticals and medical devices. And in this post, you'll be able to find crucial info about how to acquire this certificate, but first - let's see what it is and why it's important.

What Does GMP Stand For and Why is it Important?how to get gmp certificate image 1                                                                  .jpg

GMP is an abbreviation for Good Manufacturing Practice and it's a series of regulations enforced by the US Food and Drug Administration, a.k.a. FDA. Essentially, GMP is FDA's primary tool that ensures adequate control and monitoring of the manufacturing processes.

Abiding the regulations of this practice is a must for every supplement company. This helps to establish proper quality control, which leads to purer and better products as a result.

And through GMP, the Food and Drug Administration guarantees that the products meet their quality standards.

Now, the regulations set by GMP demands a responsible, quality approach to manufacturing. This is meant to help manufacturers with minimizing (or completely eliminating) cases of:

  • Mixups
  • Contamination
  • Errors

It's crystal clear that by utilizing such good manufacturing practices, the FDA is waging war on shady manufacturers and companies with a questionable reputation and dubious ingredients. This is a brilliant way to safeguard consumers from buying ineffective and potentially harmful products.

And FDA even went a step further to make sure that firms comply with GMP regulations. If a company fails to abide by the set rules, the consequences could be severe, to put it lightly. Repercussions include:

  • Fines
  • Seizure
  • Recall
  • Jail

The Importance of GMPs

There are two key aspects that make GMPs so vital. On one hand, we have the fact that consumers can't tell whether or not a product is safe by touching, smelling or just looking at it.

On the other hand, testing a product might sound like the best option, however, a manufacturer may test only a small portion of a particular product (few hundred capsules, for instance). And if there are millions of capsules available from the same product, it becomes obvious that this approach is far from optimal.

For that reason, it's imperative that supplements, drugs, certain foods etc. have to be manufactured under practices required by the GMP's control and regulations, which eventually make sure that the word "quality" is part of the design and overall manufacturing process at every level.

Here are a few good examples of how GMP and the related rules make the supplement industry a safer place:

  • Facilities in stellar condition
  • Adequately maintained and calibrated equipment
  • Fully trained and appropriately trained employees
  • Reliable and reproducible processes

And even more specifically, GMP addresses certain issues directly related to the manufacturing process of a company and even its reputation. These include:

  • Sanitation
  • Hygiene
  • Record keeping
  • Personnel qualification
  • Process validation
  • Equipment verification
  • Complaint handling

Now that you're familiar with the basics and most importantly, why following the GMP guidelines is a good idea, it's time to focus on the how a company can get this certificate.

 How  Did StockNutra GEt a GMP certificate?

Receiving a GMP certificate might not be the most difficult thing to do, although there are certain elements to consider when you decide that you need this certificate.

First and foremost, there are specific steps when it comes to getting GMP certified and It's your best bet would be to follow them:

  • For starters, you have to become a member of the NPA (natural product association) and then you have to submit a different registration for the NPA GMP Certification Program
  • Have a higher-up to visit the NPA GMP training seminar. This revealing seminar is attended by 1000+ people who represent more than 6500 brands
  • The information that you gathered from this seminar, as well as the NPA Self-Assessment Questionnaire in order to organize an internal assessment on how compliant with the current NPA GMP standards your company is
  • Then check the results of this internal assessment and order a gap analysis. This way, you'll be able to single out areas that aren't compliant with the guidelines and standards. After that, you have to take preventative measures or a plan, so that you can discuss the audit findings
  • If you need extra GMP resources, you can order materials from the NPA GMP program. They have been specifically created to help companies that want to implement good manufacturing practices, or in other words - to get GMP certified by NPA.
  • Alternatively, you can also hire an industry consultant who will work with you on organizing the internal audit and he can also be a part of the follow-up tasks. And keep in mind that you can't use the same industry consultant to carry out the GMP third-party audit - even if he is one of NPA's authorized GMP auditors
  • Get in touch with a licensed third-party auditor around six to eight weeks before the needed audit timeline, so that you can request quotes and arrange your audit
  • Finalize third-party audit plus all the needed corrective actions, thus receiving an "A" rating
  • After you are awarded this "A" audit rating, your auditor sends an audit report with his or her suggestion for the certification to NPA
  • Then NPA reviews the report and recommendation that they received. If all goes well, the association delivers a letter, specifying the terms of certification and then your company sends the signed letter with the certification fee back to NPA

And voila, you now have your own GMP certificate. It should be noted that this certificate is valid for two full years, but there are certain criteria that your company has to meet on a regular basis during this period, in order to keep your certificate:

  • Continue to be an active NPA member
  • Comply with all NPA supplier membership obligations
  • Sustain compliance with the NPA GMP standards and terms of certification
  • Pay the annual fee for the certificate
  • Be eligible for re-auditing every 2 years

Okay, we've covered the essential steps needed for getting a GMP certificate. What about all the fees and the overall cost though?

How Much Does the GMP Certificate Cost?

First, there's the program registration fee that costs $250 and then there's the annual certification fee of exactly $1000. These are all paid directly to the NPA, so anything related to the third-party audit isn't included.

When it comes to the aforementioned third-party audit, the price for that service is negotiated face-to-face with approved auditing companies. The price is based on how much time it took for that company to complete the audit, as well as any follow-up activities and even the travel time and expenses of the auditor.

At the moment you can expect to pay around $1600 to $2000 for an eight-hour day. To put things into perspective, here in the US, the audit of a small to medium-sized company with 1 facility would take four to five days on average. Logically, the same process for foreign companies is going to take longer due to the different language, the need for document translation etc.

Always make sure that the supplement manufacturer you're working with is GMP certified

That's essential because as already stated, the repercussions for not abiding by the regulations set by the FDA could be severe. Generally speaking, a quick look at the website of a given company could reveal whether or not they have a GMP certificate.how to get gmp certificate image 2                                                                  .jpg

Your brand will only benefit from receiving your supplements from a trusted and certified manufacturer. For example, we atStockNutra are GMP certified, we are 100% compliant with all needed FDA label regulations and our manufacturing processes could give you an idea of what to look for when choosing a supplement manufacturer:

  • FDA labeling competence and guidance
  • Quality control that inspects the whole manufacturing process closely
  • Pharmaceutical-grade quality
  • Environmentally-friendly facility

You have to remember that the FDA is monitoring the whole supplement industry closely, especially as it's constantly growing in popularity, more on more companies are emerging onto the scene and there are even more people who are buying supplements nowadays than ever.

So ultimately, being compliant with the current regulations and rules is essential. And even if your company is not actually manufacturing supplements, it's in your best interest to find a suitable, reliable and above all certified partner that will supply your brand with quality and safe products.

References:

  1. Recommended Steps to NPA GMP Certification - http://www.npainfo.org/NPA/EducationCertification/RecommendedStepstoNPAGMPCertification.aspx