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Dietary Supplement Manufacturer’s Future Depends on CGMP Certification

Dietary Supplement Manufacturer’s Future Depends on CGMP Certification

CUSTOMER PROFILE

In Twin Falls, Idaho, Canyonside has been manufacturing custom dietary supplements in powder, capsule and liquid formats for more than 30 years.

543 SKUs (raw materials, components, packaging)
65 formulations
35 employees

CHALLENGES

CGMP certification required
Difficult to track and trace data
Time-consuming, error-prone manual density conversions
Complex, time-intensive substitution verification
Lack of data for cost of goods sold
Challenging to prepare for audits

SOLUTION

Mar-Kov Batch Control & Inventory Management

RESULTS

CGMP certification on track
Instant access to trackable, traceable data
Rapid, automated, 100% accurate density conversions
Simple, at-a-glance substitution verification
Critical business insights with cost of goods sold
Easily and quickly audit-ready

CANYONSIDE’S FUTURE GROWTH DEPENDS on CGMP certification because retailers like Amazon, Walmart, Costco and Walgreens now insist on it.

“We needed trackable, traceable, accurate data and Standard Operating Procedures (SOPs) to become Current Good Manufacturing Practice (CGMP) certified because up to 90% of our sales will require it – Mar-Kov is helping make it happen,” says Tom Atkin, director of supply chain, Canyonside Labs. “Once we have CGMP certification, we’ll be able to attract new customers and manufacture products requiring CGMP certification for existing customers.

CGMP certification, which is enforced by the U.S. Food and Drug Administration (FDA), was the only way forward for Canyonside. More than ever before, Canyonside’s biggest customers and their future customers sell to retailers that demand CGMP certification.

“CGMP is a hot topic in terms of regulation and marketing – nobody wants their products rejected or flagged by Amazon or any other retailer,” says Tom

“CGMP is a hot topic in terms of regulation and marketing – nobody wants their products rejected or flagged by Amazon or any other retailer,” says Tom

Tom Atkin
Director of supply chain, Canyonside Labs

ACCURATE DATA, REPEATABLE SOPS

For the CGMP, Canyonside needed instant access to accurate, current data (inventory, cost, formulation). The company also had to prove operators and line employees always follow its SOPs. Employees recognize compliance is mandatory because Mar-Kov issues “stops” if employees miss a step. For instance, Mar-Kov asks if ingredients have passed their expiration/retest dates. If not, employees can’t move on to the next stage.

“Mar-Kov is a reinforcement and reminder to employees who may be more focused on completing their assigned tasks than double-checking every single thing they do,” says Tom. “It’s also really helpful from a CGMP perspective.”

DENSITY CONVERSION – SO SIMPLE, SO CRITICAL

Even before CGMP requirements inspired the move to Mar-Kov, Canyonside’s new management team knew the previous owners’ systems were problematic. After working in those systems, managers knew they were outdated and couldn’t connect all aspects of the business – sourcing, inventory control, mixing and blending, encapsulation, finished goods production, and shipping.

Although Canyonside had vetted multiple platforms, they hadn’t found one that met their needs. A Canyonside chemist and formulator recommended Mar-Kov because of its many capabilities, particularly its density conversion.

“Mar-Kov’s density and unit conversion really sold us because every day, our employees had to manually calculate hundreds of density and unit conversions,” says Tom.

The weight to volume density calculation is simple. But in Canyonside’s experience, no other platform or software performs it as seamlessly or as accurately as Mar-Kov. In fact, some don’t offer density conversion at all.

“With Mar-Kov’s density calculation, our purchasing, inventory and recipes are always accurate,” says Tom.

Users enter the ingredient’s specific gravity or density and Mar-Kov converts the volume to mass. Mar-Kov saves time and eliminates manual density calculation errors. Before Mar-Kov, employees spent far too much time adjusting the cost of goods sold and assigning them to general waste or loss.

“Our inventory and recipes are correct because Mar-Kov handles everything,” says Tom. “We know if it’s in-stock, how much we have and the expiration date.”

In addition, Mar-Kov automatically converts every type of weight and volume measurement unit, for example, kilograms, grams, liters, pounds, gallons and even moles. As a result, Canyonside orders ingredients in the suppliers’ units of choice to ensure the purchase orders and inventory are correct.

INSTANT SUBSTITUTION VERIFICATION

CGMP certification also requires ingredient trackability and traceability – Mar-Kov delivers. It assigns each ingredient a single unique Raw Material Identification Number (RMID). It doesn’t matter how many supplier/manufacturer combinations are associated with that ingredient.

Before Mar-Kov, Canyonside’s systems gave each ingredient and each supplier/manufacturer combination an RMID. More than 20% of Canyonside’s raw ingredients had at least two approved RMIDs and some had as many as five RMIDs. If the ingredient specified in the formula wasn’t available, mixers, managers and even purchasers spent hours figuring out which substitutions had been approved.

“Mar-Kov makes it incredibly simple for us – one number per ingredient,” says Tom. “In the past, substitutions were unbelievably confusing – a nightmare that occasionally stopped production and delayed deliveries.”

MANAGING MARGINS WITH DATA ANALYSIS

Canyonside also uses the accurate, timely data to better understand and manage margins. Mar-Kov tracks direct labor and recipe yields and the materials lost between the blending and encapsulation phase.

Does the machine need to be reconfigured, maintained or replaced? Do the operators need more training or support? Can the margins on a product be increased by reducing costs or is a price increase necessary? Which products and customers are worth keeping? Should certain products be dropped? What type of customers are worth pursuing?

“Mar-Kov helps us figure out how profitable we are and how to improve margins,” says Tom.

Even before Canyonside integrated its weigh scales, Mar-Kov discovered a key ingredient was 30% below the required quantity and identified the root cause.

“Mar-Kov prevented a potentially devastating error and showed us what led to it,” says Tom. “To solve it ourselves, we would have had to physically check every ingredient bag – a nearly impossible task.”

ALWAYS AUDIT-READY

When the FDA learned Canyonside was operating as a new business with different owners, an audit was in order.

“The FDA auditor was impressed with how proactive we’ve been and the effort we put into being compliant,” says Tom. “Mar-Kov was a big part of that.”

As Canyonside looks beyond the CGMP-certification audits, the company knows Mar-Kov provides instant access to the accurate, trackable, traceable reports and data the different auditors expect.

“We’ll be ready – because of Mar-Kov,” says Tom.

AFFORDABILITY, DEEP CAPABILITIES

Canyonside continues to appreciate Mar-Kov’s many capabilities as well as its affordability. Just 30% of Canyonside’s employees are concurrent users, so Mar-Kov’s concurrent user pricing offered significant savings over per-employee models.

“Competitors offered fewer capabilities and cost up to 350% more,” says Tom, who notes Canyonside’s tech-phobic bottling lead readily accepted Mar-Kov because it’s so easy to use.