GMP – What is it and Why is it Important?

GMP is an abbreviation for Good Manufacturing Practice.  It is a series of regulations enforced by the US Food and Drug Administration (FDA). Actually, GMP is the FDA’s primary tool ensuring adequate control and monitoring of the manufacturing processes. Not all manufacturing companies receive a GMP certification.

Consumers of vitamins / supplements and other health products have no way of tasting, smelling, touching, looking at, product testing or evaluating the quantity and quality of the ingredients in a container.  This is why GMP is so vital to keeping consumers safe.  GMP is really an evaluation of saying a specific manufacturing company is providing a quality product. Those products are made correctly and to the highest degree of professionalism in the entire manufacturing process.

Supplement and health related manufacturers are increasing each year. Their goal is to capture some of the profits from this fastest growing industry worldwide.  Not all supplement manufacturers are created equal.  Products on the marketplace have a wide variety of quality and control.  This alone is a key reason to purchase any vitamin / supplement or any health related product from only a GMP certified company. Look for the GMP on the product label for your safety.

The GMP Certificate Helps to Eliminate Various Manufacturing Daily Items such as:

• Contamination
• Errors
• Mixups
• Sanitation
• Hygiene
• Record keeping
• Personnel qualification
• Process validation
• Equipment verification
• Complaint handling
• And many other checked items.

 

 

1.  A manufacturer becomes a member of the NPA (Natural Product Association) and then submit a registration for the NPA GMP Certification Program

2.  Have a high ranking manufacturer staff member visit the NPA GMP training seminar. This revealing seminar is attended by 1000+ people who represent more than 6500 brands.  The information 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 a manufacturing company is.

3. Check the results of this internal assessment and order a gap analysis. The gap analysis will  single out areas if any which are not compliant with the guidelines and standards.

4.  Establish a plan to take preventive measures to discuss and address the audit findings. At this point a manufacturer might need extra GMP resources, which they can order materials from the NPA GMP program. They have been specifically created to help companies wanting to implement good manufacturing practices, to get GMP certified by NPA.

5.  Manufactures may also hire an industry consultant who will work on organizing the internal audit and the consultant can also be a part of the follow-up tasks. This consultant cannot be  the same industry consultant to carry out the GMP third-party audit – even if he is one of NPA’s authorized GMP auditors.

6.  Get in touch with a licensed third-party auditor around 6-8 weeks before the needed audit time line to request quotes and arrange your audit.

7. Completing the third-party audit plus all the needed corrective actions, hopefully the manufacturer receives an “A” rating.

8.  After the manufacturer is awarded this “A” audit rating, the manufacturer auditor sends an audit report with their suggestion for the certification to NPA

9. NPA reviews the report and recommendation they received. If all goes well, the association delivers a letter, specifying the terms of certification and then the manufacturer sends the signed letter with the certification fee back to NPA.  After all this process, if no problems are found, the manufacturer now has a GMP certificate.

10. It should be noted that this certificate is valid for two full years.  However there are certain criteria a manufacturer 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.

11.  We have now covered the essential steps needed for getting a GMP certificate.  Let us describe the fees and the overall cost to obtain a GMP certificate.

12.  The GMP Certificate Cost: The program registration fee costs $250 and then there is the annual certification fee of $1000. These are all paid directly to the NPA, so anything related to the third-party audit is not included.

13.  The aforementioned third-party audit, the price for their service is around $1600 to $2000 for an eight-hour day. To put things into perspective, here in the United States, the audit of a small to medium-sized company with 1 facility would take four to five days on average.

The FDA is monitoring the whole supplement industry closely.  Especially since the industry is constantly growing in popularity.  More on more companies are emerging onto the scene manufacturing all levels of quality products.

In addition to many new manufactures in the health industry, there are even more people who are buying supplements nowadays than ever before in history.

Ultimate conclusion: Buying vitamin / supplement / health related products are essential to be compliant with the current regulations and rules. The GMP certification is in the best interest of the consumers safety, a valuable asset of the FDA.

Steps to GMP Certification

For those who love reading all the government red tape of the above issue, there are many government web site postings above how companies acquire a GMP. There are also different rules for companies desiring certification if your company resides outside the USA. This is not an easy process or inexpensive to obtain the certification and it is suggested you have legal assistance.