Smaller and emerging dietary supplement manufacturers face challenges in seeking their way to cGMP certification. I understand this well. As a Quality Management Systems specialist, our planned monthly virtual meeting with the leadership team is often postponed. And if you are a manufacturer, you are well aware of the reasons.
Most often, it is simply that production takes precedence. Getting the product made, shipped, and invoiced is the priority. Some members of the leadership team are on the production floor helping out. This is not a bad thing, and as a Driver of the Quality process, I get it.
Cost of cGMP for Supplement Manufacurers
#1) You have to be able to afford the cost of my service, and that won’t happen unless receivables are healthy.
#2, having adequate floor production personnel is always a big challenge.
The key to attaining cGMP status for emerging supplement manufacturers
The key to attaining cGMP status is establishing an action plan, setting specific action items, and setting goal dates for completion. It is also essential to regularly reset these goal dates to ensure ongoing progress. I can always rework the Monthly Action List in collaboration with the manufacturing leadership team. The steady mantra that is consistent in this process is the following:
Then, emerging supplement manufacturers enter the production chain just trying to survive. Get the product out. Get it invoiced, and collect payment for goods delivered. I get it. Taking the long view to achieve 100% cGMP compliance is a significant challenge.
Aspects of cGMP for Emerging Supplement manufacturers
1. Standard Operating Procedures (SOPs) must be written for all operational sections. Nothing is confirmed in the compliance world unless it is written, documented, and consistently applied.
2. The operating procedures must be consistently implemented and adhered to.
3. This requires periodic training for operations and process personnel. (as in a written and logged schedule).
4.) The first place it starts is with sanitation. I have trained teams on the production floor and provided protocols for cleaning equipment, surfaces, and the laboratory, among other areas. The only way it works is for leadership of the emerging supplement manufaturer to take ownership and promote it throughout the team. A key component of developing a winning cGMP culture is through a recognition and incentive program at the production floor level. People need to feel that they are essential to the goal. The goal is to deliver the highest-quality product possible, consistently meeting the product specifications.
“cGMP Success is not final, failure is not forever, your courage to restart is what counts.”
Nutrition 50 “helping the emerging supplement manufacturer to achieve the highest level of quality compliance continually.”
