GMP – What is it and Why is it Important?
The GMP Certificate Helps to Eliminate Various Manufacturing Daily Items such as:
- Record keeping
- Personnel qualification
- Process validation
- Equipment verification
- Complaint handling
- And many other checked items.
The GMP label on a product helps to establish proper quality control, which leads to purer and better products as a result. As in all manufacturing it is important to have quality control. Each manufacturing facility has to pass numerous checks / inspections before they are given a GMP certificate from the FDA.
All Products sold by LasVegasDiet.com have GMP certification
GMP addresses issues directly related to the manufacturing process of a company and even its reputation. Any manufacturer producing products not up to the minimum standards of the FDA will find themselves with the following problems of losing their GMP standings and possible Fines / Seizures / Product Recall
It is imperative supplements, drugs, certain foods etc. have to be manufactured under practices required by the GMP’s control and regulations. These controls and regulation eventually make sure 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
Obtaining a GMP certification is a very long and time consuming process with many steps to complete before a manufacturing company can proudly state they have received GMP certification.
The following is one way a company can receive a GMP classification.
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 and the GMP to the Consumer Rescue
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.
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