GMP’s, Training, and Plant personnel

One of the biggest pitfalls for a dietary supplement manufacturer is not following strict GMPs. Being lax on GMPs will get you in trouble with your customers when they come to do audits and can cost you valuable business. It can also lead to serious consequences with the FDA. Product recalls and forced plant closures to fix violations can be expected if GMPs are not being followed. An FDA audit is not something that anybody wants to go through, even if you are following strict GMPs. See the links section for FDA enforcement actions taken this year.

One of the biggest challenges as Quality is getting all of the production employees to follow GMPs every day. There are a couple of approaches that should be taken together to accomplish this.
1. Train all of your employees in GMPs. This way everyone in the plant is aware of what rules they need to follow to comply with the regulations. This sounds straight forward and logical, but in practice this can get pushed to the back burner as more immediate production issues occupy your attention. The irony of this is that a lot of these issues actually stem from lax enforcement of GMPs. Train all of your quality staff in the GMPs and emphasize what to look for when they are out on the production floor. A good way to do this is to do periodic internal audits, preferably monthly or quarterly. This way all of the quality staff gets to see concrete examples of the proper way to follow the GMPs as well as any GMP violations that the audit finds. Along with this, emphasize to the quality staff that they are the examples for the rest of the plant to follow. Emphasize how important it is for them to strictly adhere to the GMPs.
2. Office staff, upper management, and owners need to strictly follow the GMPs when they are out on the production floor. If you have management or owners not following the rules then the production employees tend to think that “if the managers aren’t following the rules then I don’t have to either”. This is a very bad habit to allow to form.
3. Have quarterly GMP refresher training to reinforce how important it is to follow the regulations. Get all the employees involved in creating an atmosphere of compliance. Use incentives to encourage employees to point out deficiencies and come up with solutions. They are the ones who are working on the production floor every day. They see the deficiencies, so getting them involved will make it that much easier to comply.

There are independent GMP certifying agencies that can help your company become compliant and lend credibility to you GMP program. NSF International is one of the world leaders in independent certification.
NSF International, The Public Health and Safety Company™, a not-for-profit, non-governmental organization, is the world leader in standards development, product certification, education, and risk-management for public health and safety.
These guys will certify that your production facility is following strict GMPs, all of the necessary quality systems and standard operating procedures (SOPs) are in place and being followed, and all of your documentation is in place and being followed. Having the NSF certification hanging on you wall for all of you visitors to see is a great selling point. It makes the customer feel all ‘warm and fuzzy’ inside. What this shows is that your company is following all of the procedures that are required to make a quality product that is safe for the consumer and, as important, a product that can be consistently manufactured to the customer’s specifications.

Creating an atmosphere of compliance can be challenging but the rewards will far outpace the pains it takes to get there. Better audit scores with your existing customers will lead to more purchase orders and impressing new customer will lead to more business. GMPs are the foundation to creating a growing business.