Dr. Stephen DeFelice coined the term “nutraceutical” from “nutrition” and “pharmaceutical” in 1989, and in 2020 it’s still yet to be clearly defined or internationally accepted. How is quality measured across all segments of the manufacturing process when there are no set standards? In a customer-driven industry that constantly changes to meet the trends and demands of the market, the global raw material industry is shifting from being a mere supplier to being part of a business’s standard operating procedure (SOP) process. Manufacturers not only want to know every detail of the growing process but where the finished product is going. Extending the control of the supply chain management to “growing,” and then a step further to post manufacturing with track and trace and serialization, improves the integrity of the overall supply chain.
Nutraceutical manufacturers are required to consistently produce quality products at competitive prices, meet the demand of their consumers and regulatory bodies, all while managing a healthy bottom line.
In a market saturated with more of the same products, manufacturers want it all to gain competitive advantage in the marketplace. I want a product that is grown biodynamically based on regenerative principles on a family owned forest in Indonesia. The land is rich in fertilizer from the teak canopy that provides just the perfect amount of shade to grow the very best product in the world. And as a manufacturer I will develop a SOP that provides proper training for the growers, pickers and packers and further to maintain the integrity of the land. As a responsible manufacturer I want to maintain control of my stock with track and trace capabilities.”
In the global supply chain, verification and testing are vital in maintaining quality and sustaining the market. Once the ingredient quality has been verified, the next and also critical step is to define the manufacturing area. Choosing an established GMP or cGMP (good manufacturing practices and current good manufacturing practices) ensures that nutraceuticals entering the market meet specifications for purity, strength, and composition. While GMP regulations provide the groundwork for manufacturing practices, it is the SOP that is the true infrastructure of product development. Many nutraceuticals possess multiple therapeutic properties which also means additional ingredients, so when comparing SOPs in the nutritional space versus the pharma space, the task is far more daunting in nutraceuticals due to the number of ingredients in many formulations.
Nutraceutical manufacturers need to keep up with the FDA’s (U.S. Food and Drug Administration) compliance standards, according to Rule 21 CFR Part 111. cGMPs work very much like the Kaizen philosophy implemented in the auto industry, where suppliers and manufacturers are expected to monitor, record and improve on their processes.
• Implementing cGMPs—following the Dietary Supplement Health and Education Act of 1994 (DSHEA) to make sure cGMPs are being met;
• Careful classification—as dietary supplements, nutraceuticals must be strictly controlled when it comes to their classification used in marketing; a most recent example was made of a manufacturer in New York, who was found to be flouting these norms, where products were recalled from as far back as seven years ago!
• Data capture—FDA-regulated manufacturers have to keep accurate and precise records for all their systems and processes, and trace supplement products down to the lot number;
• Labeling—labeling rules and regulations are stringent for dietary supplement products. Besides, nutraceutical providers need to submit data that confirms the ingredients used in the product are safe for human consumption, validated by tests either in house or at well know third-party labs.
Meeting these regulations ensures that manufacturers of nutraceuticals and their partners, are in compliance.
Clean and Validated
A crucial step in developing and maintaining these SOPs is continuous cleaning and validation. To prevent and minimize cross contamination of products, especially when there is batch-to-batch change over or a completely new product run. As part of that, it is important that manufacturers design their manufacturing space following a process of QBD (quality by design); quality will be the end result of the design that is set up in your manufacturing process. Quality cannot be achieved by having a single test or a single procedure; it has to be designed into the way the facility is run, so quality by design would be the mantra for manufacturers to follow. This includes selecting the right equipment for the right applications, ensuring that you follow the right cleaning and validation SOPs and more importantly, training the operators. Continual training is critical in ensuring that operators are up to date with the most modern practices and understanding of how the equipment is operated and how to ensure that products are moved safely. This delivers the best result for the consumer when they are able to receive both safe and effective products.
The other part of product quality is how we define the organizational structure; many nutritional companies look at the quality department as a policing of the manufacturing facility—they, in fact, play a vital role hand in hand with the sales and operations divisions to ensure that the customer is getting the product he or she wants. Quality, when defined in an organizational context, has a greater role to play in the nutritional industry and it is therefore also important to have the quality positions separate from the business. This allows them to ensure that there is enforcement and prevents them from sourcing to the pressures of business, so while designing the organizational structure for quality, it is vital that business is kept at arm’s length.
Track & Trace
If you are in the business of manufacturing or distributing dietary supplements or nutraceuticals, then you need to be able to track and trace all ingredients in your products. Tracking includes products, raw materials being used, test results of stated raw materials, certifications (halal/kosher/non GMO (genetically modified organism)/vegan, etc.), regulatory compliance, and product specification performance.
As part of a track-and-trace solution, what is also included to ensure quality is an automated vision system for inspection. Inspection can include verification of any number of facets in the packaging process—color of the container, level of liquids to a specified fill line in a bottle, color of the product going into a container, orientation of a container along a conveyer belt and so on. From a track and trace perspective, what is most vital is the inspection of the label, verifying the quality of the unique identifying number applied at the level of a sellable unit, which will be used to track the product through the supply chain. In pharma, this is known as “serialization.”
In other industries, it is the process of generating and applying a unique alpha numeric number, in addition to such data as expiry dates, lot number and other valuable date germane to a particular manufacturer. This is quite similar to serialization, but without the need to conform to the GS1 numbering schema found in the regulations which govern the pharma industry.
The process is accomplished at the manufacturing plant during the packaging process, on the packaging line itself. The data created can then be captured at the enterprise server level, to be made available to other partners within a manufacturer’s supply chain. In doing so, we invoke a process which establishes the chain of custody as the product moves from manufacturing to warehouse to distribution and finally point-of-sale. With the addition of geo-location and other such intelligent facets of track and trace solutions, we begin to add elements to protect against counterfeit goods entering the supply chain. Geo-location, to some degree, can also help mitigate the “grey market” issue, whereby inventory intended for a specific market mysteriously appears in another due to nefarious activity.
The industry is adopting technology to ensure that products are safely delivered to customers and preventing the sale of spurious or counterfeit products. The implementation of track and trace systems in the pharmaceutical industry, has paved way for the adoption of this benchmark in the nutritional space, albeit not as a mandate at this point.
The ability to trace the individual products, right up to the point of sale, allows for targeted quarantine of at risk finished products, and the ability to make informed decisions regarding products already with customers. It also helps with processing warranty claims and averting costly large-scale recalls. NIE
Anand Rajan is a mechanical engineer with an MBA in marketing. With more than eight years of experience in pharmaceutical machinery sales over numerous geographies, he is currently heading the engineering business for ACG in North America, with a focus on custom solution delivery.
