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Quality Deliverance

As today’s regulatory environment tightens, working with a reliable contract manufacturer brings added benefits as companies look to expand.

As companies are always looking to grow their product lines, market share, customer base and, of course, sales, there are many factors they take into consideration when looking to contract manufacturers: cost savings, speed, quality and skill are just a few of them.

Most choose to work with a contract manufacturer because the cost to start their own manufacturing line—along with the technical issues— proves difficult, said Steve Holtby, president and CEO of California-based Soft Gel Technologies, Inc. (SGTI). “By outsourcing production, there is no need to purchase or rent production facilities, buy equipment, purchase raw materials, or hire and train employees to produce the goods,” he said. “There are also no headaches from dealing with employees who fail to report to work, equipment that breaks down, or any of the other details that any manufacturing company must face daily. Instead, they are able to completely focus on making sales, advertising and marketing the product.” 

Every contract manufacturer promises quality; it Is trust that keeps the customer returning year after year, added Mark Wright, president of Oregon-based Health Wright Products (HWP). “It takes time, commitment and the desire to not only make promises of quality, but reinforce those promises through consistent delivery of superior customer service throughout the production process; from initial order to delivery follow-up.”

And regardless of the size of the client, the one common misunderstanding for both large and small companies is deadlines: it’s never soon enough, said Shaheen Majeed, marketing director for New Jersey-based Sabinsa Corp., with its contract manufacturing facilities in Utah. “Production planning is something that is not often understood nor explained very well, but we find telling the truth about a given timeline is the best way to help customers understand where their project stands.” 

Large and small clients both want consistent reliable service and technical expertise, added Tee Noland, senior vice president of sales and marketing at Pharma Tech Industries (PTI), a Georgiabased contract manufacturer for 40 years. “Where they differ is how they collaborate with our team. Typically larger companies have more resources and more specific requirements, whereas smaller companies have less resources and less specific requirements. Smaller companies tend to want more services in terms of development, stability and validation support than larger companies.” 

Alleviating Concerns 

SGTI is a full-service contract manufacturer, specializing in providing marketers with premium quality dietary supplements in a soft gelatin capsule delivery system. “We try to work with the customer at the onset of the project to discuss all angles and aspects of their product so that these subjects are well understood,” said Holtby. “There tends to be a misconception about the amount of time it takes to manufacture a product from the time an order is placed. In addition to time, many customers also underestimate the costs involved. As a soft gel manufacturer, we encounter some customers who are not familiar with the soft gel manufacturing process, and associate soft gel production being as a simple process, like twopiece capsules or tablets. We do our best to provide them with information to increase their understanding of our process, so that they can better formulate and choose a delivery system for future projects.” Since soft gels are a specialty delivery form, many customers do not possess the knowledge of formulation challenges. It is important to consider both the physical and chemical properties of a formula, Holtby explained.

For Sabinsa, some of the most common requests are for its granulation services. Herbal extracts are not as easy to encapsulate or tablet as people may think, said Majeed. A couple of processes may have to take place before the company can be put in proper dosage forms. “One of which is granulation, which helps to change the physical property of the herb/powder, which in turn helps to compress into a tablet, let’s say. [It] sounds simple, but there is more science and formulation involved, which many companies may not want to get into or have the proper equipment to do. So as an intermediate step, we can do that for them.” 

Testing 

Undoubtedly, the nutrition industry has been moving in a direction focused on providing safe, effective, high-value products to the consumer. In addition to the continued presence of internationally recognized certification groups such as NSF International and the Natural Products Association, the Food and Drug Administration (FDA) has taken a much stronger stance on controlling quality with good manufacturing practices (GMPs), said Holtby. “As manufacturers and marketers of these health products, it is our duty as an industry to provide them with the best possible supplements to enhance their health and quality of life.” 

In 2008 and 2009 respectively, FDA GMP compliance enforcement began examining large and medium-sized manufacturers. “The June 2010 requirements of manufacturers with less than 20 employees marked the final stage,” noted Holtby. “The added cost of analysis required by the new regulations increases the cost of production. For this reason, many small nutritional supplement companies are now looking to partner with a contract supplement manufacturer who is prepared to meet these regulations.” 

With the advent of the new GMPs for dietary supplements, contract manufacturers must advise customers of the implications of the new regulations, he continued. “It is important to have formal training programs in place to ensure that personnel have a thorough knowledge of GMPs and SOPs (standard operating procedures) and follow them. Record keeping and documentation are crucial components to ensure GMP compliance and continued certification. Complete and detailed batch records need to be maintained for traceability purposes.” 

Thus, with the more stringent requirements of the GMPs, testing on a whole is more comprehensive and time-consuming than before, added Holtby. However, it is not just the effect of the GMPs themselves, but also other systems, such as California’s Proposition 65, that add to testing times and cost, he said. “As a manufacturer, the GMPs make us responsible for all materials we use. As such, we run identification testing on all incoming raw materials. We also do purity testing, depending on the customer’s active ingredient claims.” SGTI has a variety of high-tech laboratory equipment that is used in the operation. Its lab contains two gas chromatography machines; four high-performance liquid chromatography’s (HPLCs); one atomic absorption; one ultraviolet (UV) spec; and one fourier transform infrared spectroscopy (FTIR). Most are used for potency testing, though the FTIR is mainly used for identification, Holtby said.

Moreover, Sabinsa has an in-house laboratory that takes care of all of the items that the company works with in its Utah location. “Safety and quality are the highest priorities here at Sabinsa. Nothing trumps this. From incoming raw material, be it Sabinsa ingredients or those from outside, to outgoing finished products, everything gets tested. Many customers see this as an interference in getting their product delivered, but in time they realize such testing is actually beneficial for them to stand out from their competitors,” said Majeed.

With the GMP requirements, Sabinsa’s customers are mandated to be assured of its compliance, Majeed continued. Proof comes in one of three forms: third party certification (i.e. NSF); customer audits of facilities; or government agency inspection reports. “On purchasing standards, we require vendor self audits and, when warranted, inspect vendor facilities. As a supplier of high quality ingredients ourselves, we know what to look for. On testing protocol, we go beyond the minimums of product identification and use HPLC for some products as appropriate. Of course, all products are quarantined until validation is conducted and, only then, are released by our quality assurance (QA) department. And in-process testing is aligned with our finished goods testing. Our testing capabilities are quite comprehensive.” 

Each of PTI’s sites, meanwhile, has full-scale microbial and analytical testing laboratories, said Noland. The company has also made significant investments in 2012 to expand its prescription and over-the-counter (OTC) analytical capabilities with a state-of-the-art laboratory upgrade. “We also utilize third-party laboratories in cases where clients have existing relationships or in cases where there are specialized testing requirements. With the way the regulatory environment is changing so rapidly, contract manufacturers really need to stay on top of expectations. Throughout the year, we are subject to numerous client audits by big pharmas as well as outside consultants to challenge the way we approach our quality and compliance systems. We believe our testing capabilities offer a lot of value to our clients in terms of cost, reduction of lead times and supply chain simplification. We make products to make people healthier and better off—not the opposite.”

Furthermore, HWP will produce about 1.5 billion capsules this year, and is one of the only contract manufacturers that exclusively manufactures capsules, said Wright. “We know of no other contract manufacturer that offers a 100 percent humidity controlled manufacturing area in addition to the large cold storage area; these combine to provide the highest quality capsule product available.” 

Ingredients 

One of the contract manufacturing challenges is always quality versus price point, said Majeed. “When our customers work with our ingredients, processing goes very smoothly since the ingredients are consistent. Commoditiesbased products can pose processing challenges as their properties may vary widely. We do have a lot of experience so we can generally sort these out, but we encourage customers to use our ingredients as much as possible for manufacturing as well as efficacy purposes.”

Last year, Sabinsa introduced Integrated Nutritional Composites (INC™), which created a buzz around the formulation possibilities with Sabinsa ingredients (and some non-Sabinsa ingredients) that can be delivered in a bi-layer tablet, said Majeed. “Sure, other companies can assist you in compressing bi-layer tablets—some companies we know have modified their existing equipment to handle such requests— but we house non-modified pilot scale and full-scale tableting machines. Hence, with us there is no compromise in your tableting and with our expertise in formulations, no compromise on the quality of what you’re delivering.” 

PTI has a supplier qualification and management program that it can leverage to assure quality and reliability, said Noland. “Our experience with suppliers tends to show that the lowest cost for commodity ingredients are typically the least reliable. We have found out that unreliability can equate to costs far beyond those savings that are perceived in the purchase prices. Clearly there is an important balance between reliability and cost that needs to be assessed,” he said.

In conclusion, Majeed added: “On face, the customer will almost never tell you to use a cheaper ingredient, but they will tell you if your final price point does not match what they intend to pay. We have noticed that [this] trend leads to such companies thinking of their endconsumers in terms of price and not of quality.”

“It is important to have formal training programs in place to ensure that personnel have a thorough knowledge of GMPs and SOPs (standard opering procedures) and follow them. Record keeping and documentation are crucial components to ensure GMP compliance and continued certification. Complete and detailed batch records need to be maintained for traceability purposes.”

— Steve Holtby, President and CEO, Soft Gel Technologies, Inc. (SGTI)

Extra! Extra!

Visit www.niemagazine.com to learn about the financial rewards of faster product testing.

FORMOREINFORMATION:

Celsis Rapid Detection, (800) 222-8260

Health Wright Products, Inc.,(503) 722-4344

Pharma Tech Industries, (706) 246-3555

Sabinsa Corp., (732) 777-1111

Soft Gel Technologies, Inc.,(800) 360-7484