Laying the foundation for quality – article

As COVID-19 pushed the global dietary supplement market past the $150 billion benchmark with record growth of 9.5%, the question of what makes a quality product is top of mind for consumers more than ever before. While retailers have long been the gatekeepers of quality, as e-commerce becomes a more predominant sales channel, consumers are seeking transparency across the supply chain. Consumers are starting to understand that quality starts with ingredients and formulation. And ultimately, it starts with a commitment to quality by the people on the starting end of the supply chain, like Contract Pharmacal Corp (CPC).  

While some manufacturers may be caught trying to raise the bar as consumers increasingly seek transparency, for a company like CPC, which is celebrating 50 years as a contract development and manufacturing organization, it’s easy to help clients meet consumer expectations. Quality has been baked into the company’s DNA since its inception in 1971. In fact, it’s written into the company’s values statement with Quality Assurance noted as “the cornerstone for how we develop every product from start to finish.”

As the company works with brands in developing, manufacturing and packaging pharmaceutical needs, including dietary supplements, this commitment enables CPC to exceed customer expectations, and to go above and beyond industry regulatory standards.

“Fifty years ago, John Wolf, our co-founder, had a vision to help companies bring quality pharmaceutical-grade products to consumers. Now, our customers depend on us for quality,” explains Jeff Reingold, Chief Operating Officer. “People assume quality, but you have to prove quality.” To illustrate his point, Reingold notes that the company’s last eight FDA inspections have resulted in no observations. “This is an example of why people can put their trust in the quality of a product from us and trust us to create a brand that has expectations in the marketplace,” he explains. 

Quality Testing

As the company’s initial tablet-making focus has evolved with consumer demand to offer capsules, pellets, powders and effervescents, so too has the testing within its full-service cGMP laboratories to include validated gold standard techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Inductively Coupled Plasma Spectroscopy (ICP), UV-Fluorescence Spectroscopy, Mass Spectrometry, wet chemistry, PCR and microbiological testing.

Reingold emphasizes that product offerings and testing standards could not have evolved if quality was not a fundamental pillar of the company. “The systematic approach to quality from the earliest stages of analytical development has been instrumental in informing method selection to improve specificity and sensitivity.  This has enhanced our ability to conduct high throughput QC testing of diverse analytes from a myriad of sample substrates with greater precision and accuracy. Without the organization’s commitment to quality as an essential component of the decision making and culture, addressing all the things that go into creating quality products would be more difficult,” he explains.

Quality, in fact plays into every decision the company makes, which is critical as CPC now manages 65 customers worldwide and makes over 600 different products per year, with an annual bottling capacity of 300,000,000 and annual solid-dose capacity of 20,000,000,000. “Whether we buy a new piece of equipment or we are designing a new facility, from the onset, we think ‘how does quality work into this?’ versus what does it look like after the fact,” Reingold says.

Time-tested Information Tracking

Another key transformation in tracking quality over the company’s 50-year tenure has been the evolution of its quality management system (QMS), which Reingold says allows the company to better track, trace, trend and make information much more visible. “The QMS system helps us steer the ship. With information, we can make better decisions as leaders. With information, we can help define where we need to put resources and where are the best opportunities for improvement. It helps the vision and forward thinking,” he explains.

The QMS allows the company to be proactive in evolving the business, while also being transparent. Being able to share information throughout the organization is vital, especially during the 30 regulatory audits CPC hosts annually. “We run the business with transparency and openness for each audit and partner visit. We always look to climb higher. We want to hear about other expectations and practices that might improve or strengthen our ability to perform. Audits are important. We take them seriously and share what we learn with the team,” Reingold says.

Sharing information, says Reingold, is not only important internally, but for the betterment of the global dietary supplement marketplace. “For the global marketplace, if we approve or disapprove of an ingredient, sharing that information is critical. If a raw material shows up and we test it and reject it, we don’t want to just give it back to the vendor. We want to track and verify it gets destroyed rather than being sold to someone else.” Sharing information at this level is key to upholding the quality of the industry as a whole explains Reingold. “The industry builds its own level of reputation. We invest a lot of energy and resources in maintaining quality and making sure the products we are producing meet expectations. But, we have to be confident in what we are doing from a quality perspective as both a company and as an industry,” he explains.

It Starts with People

CPC’s quest for quality started with the vision of its founder. Today, it’s maintained by the company’s more than 1300 full-time employees and the partners it chooses to work with. From R&D to client-facing or internal project management, CPC has people around the globe with an eye on everything from sourcing and procurement to production and regulatory compliance. These are the teams, says Reingold, that walk with clients from ideation to commercialization. These are the people that are always thinking of their partners and how to do better.

“All of this sets us apart from the transactional relationship of contract manufacturers. We are partners in a long-term relationship with our clients. We grow together.” And as the company looks into the future, at processes and new opportunities, Reingold emphasizes that every evolution within the company will continue to ladder back to quality for the next 50 years and beyond. “When we look to grow the business, we have to look at the business as a whole, whether we want to add more tablet presses or we need to buy, sample and test more raw materials. The question is always, ‘how do we evolve and grow the whole business while maintaining the highest level of quality.”

Learn more on cpc.com