How to choose the right contract manufacturer of dietary supplements?

IOC was the first company in Poland to offer its services exclusively in the field of contract production.

A strictly defined specialization from the beginning of the company's existence as a contract manufacturer of dietary supplements and cosmetics has given us the opportunity to gain unquestionable experience in the narrow scope of "contract production". Professional contract production of dietary supplements is significantly different from producing supplements under your own brand or occasionally producing supplements for your clients.

We encourage you to read the article below, which was based on the text from the website www.nutritionaloutlook.com by Kimberly J. Decker.

 

We hope that at the next meeting we will be able to discuss the following issues with you.

How to choose a contract manufacturer of dietary supplements?

Anyone who has tried online dating understands that some relationships are too important to be left to chance. Being able to verify a potential partner's profile and eliminate mistakes is much more efficient - and more civilized - than trying to guess whether the person on the other side of the screen is Mr. or Mrs.

For this reason, a potential client of a contract manufacturer of dietary supplements may wonder whether someone should launch something like a "dating website" to choose the right partner for contract production. 

After all, with today's rising costs, accelerated competition and frequently changing regulations, which significantly increases the importance of choosing a competent and reliable co-producer, there is no time for blind dates.

But don't expect a computer algorithm to make the choice for you, it's not possible today. Until that happens, dietary supplement marketers will have to find "true love" the old-fashioned way: go out, meet potential partners, and ask the right questions. With patience and perseverance, you and your partner can end happily.

Contract manufacturing: the new obvious

Co-production has become such an obvious standard in the supplement industry that it is difficult to remember when companies produced and sold products without outside help. “Contract manufacturers definitely play an important role,” says Tim Bray, vice president of Pharmachem Laboratories Inc. (Kearny, NJ). “Based on the additional costs of new regulations and the complexity of products brought to market, we see increased demand for the contract manufacturer role.”

Research laboratory IOC Production of dietary supplements - Stage of the contract production process

Some of the challenges come from the strength of the industry itself. Consumers have new "tools" to manage their health, notes Olivia London, senior operations manager, National Enzyme Co. (NEC, Forsyth, MO), moving toward supplements as a cost-effective, more "holistic" alternative to pharmaceuticals. “This has created greater demand for dietary supplements,” he says, “and contract manufacturers are facing this challenge.”

More significant, however, is the implementation since 2007 of Good Manufacturing Practices (GMP) for dietary supplements. By enforcing appropriate controls during production, packaging, labeling and holding, as well as extensive testing, validation and record-keeping for compliance, placing more demands on existing production lines.

But in the end, says Shabbir Akand, vice president of sales and marketing, NHK Laboratories Inc. (Santa Fe Springs, CA), GMP is “a step in the right direction.” Before its passage, “contract manufacturers could technically just branch out and go into business with minimal investment,” he says. This is no longer the case. And although "it was a long road to compliance," he adds, "it was also an opportunity to improve internal processes and obtain higher quality products."

Elimination of what is unnecessary

New requirements, of course, come at a cost, and in this case, those costs include: increased investment in equipment, analysis and staff, all of which can be "time-consuming and financially difficult for companies interested in bringing products to market," says James McNeal, quality control inspector at the NEC. “In this case, a manufacturer of high-quality products can be invaluable. A partner's knowledge of these requirements and established procedures can significantly increase confidence that the product is safe, effective, consistent and compliant.

Just consider the equipment the company has. Whether producing tablets, capsules, soft capsules (“soft gel”) or other forms, “there is no one device that can do everything,” says Bray. “There are many types of granulators and many other pieces of equipment that could break the bank for many companies if they tried to invest in all types and phases of production.” By taking on these capital-intensive purchases upfront, the costs of a contract manufacturer would be "unsustainable to handle on its own and still be competitive in the marketplace," he says.

A similar division of costs occurs in the case of analytics - also emphasized in the new requirements - as well as in sourcing raw materials, quality control and even employees. Eugene Ung, CEO, Best Formulations (City of Industry, California), notes additional expense workers' compensation and health insurance, as well as the need for additional hiring to help implement reforms to legal requirements. “Management systems can dictate the elimination of what is unnecessary while investing in achieving greater operational efficiency,” he says, adding that their internal knowledge of the industry allows them to extract efficiencies, for example, from the supply chain itself.

In fact, customers can help make the right decisions by forecasting their production needs so that their dietary supplement contract manufacturer can “strategically” work with their suppliers to maintain proper rotation of raw materials and packaging, says Akand. “This helps reduce costs by locking in high-quality raw materials at a more competitive price.” It also eliminates production gaps, reduces downtime, allows for greater expenditure and much more - savings allow you to direct capital where it belongs: to marketers and to creating your own brand.

But most importantly, contract manufacturers guide their clients through today's uncharted regulatory territory. “Gone are the days when you could design a product on day one and have it ready to ship on day five,” says Ung. “Regulations continue to evolve, and we continue to adapt and inform our customers of changes as they occur.”

Question time

What to avoid? Finding the right partner and creating a mutually productive business relationship takes work. I do not recommend using "occasional hunting". “Price shouldn't be the most important part of the conversation,” Bray says. Only after signing a joint confidentiality agreement and having what he calls a “frank discussion” should the parties “put pen to paper and review the final price of the project. If we enter into price, which is the only determinant, then we may find that in the end we will pay much more.

Contract production of supplements. Contract production of dietary supplements. Contract production of medical devices. Production of dietary supplements. Production of dietary supplements on request

Beyond that, the trick is that it's co-creating a business relationship, so it comes down to asking the right questions, says London, to "determine not only the best contract manufacturer for your needs, but also determine whether the price for the product provided by that manufacturer contract is worth the additional support and level of service he will provide us.”

Among the questions he suggests: Do you offer lab testing? What certificates do you have? Are your employees competent, with extensive contracting and manufacturing environments? What is your regulatory process and how can you help me comply with applicable legal requirements? What is your quality control process? What type of audits do you perform: Internally? External? And how often?

Shaheen Majeed, Chief Marketing Officer of Sabinsa Corp. (East Windsor, NJ), adds that a client of a dietary supplement contract manufacturer should ask about the manufacturer's organizational structure and growth opportunities, "especially if you have a product that is doing well in the market." Don't neglect the value of experience. Ask how long your partner has been in the industry; Relationships with suppliers built during this time can result in savings. “Or maybe you won't think to ask for something basic,” Majeed says, “ask if they've made similar dietary supplements before.” The more familiar they are with your product, the better they will be able to produce it.

Even questions about ecology are fair game. Bray states that the issue of sustainability often comes up. “We discuss which solvents are used and how we test for residual solvents in the finished product,” he says. “Our employees are always talking to our suppliers about the best alternatives. New methods for analyzing nanoparticles require a constant update of our analytical capabilities.

If the candidate doesn't agree to this, be careful. “A contract manufacturer should be open to answering questions,” Ung says. And try to get references if possible. While non-disclosure agreements may bind contract manufacturers to providing access to existing customers or the production facility itself, raw material suppliers are "a good way to check," Ung says.

Machines for the production of dietary supplements - TABLET MACHINE - manufacturer of dietary supplements production of dietary supplements manufacturer of supplements contract production contract production of dietary supplements production of supplements dietary supplements manufacturer

Certification

Often, other companies granting certificates can open a window to the competence of a co-producer. As Ung explains, “Because the industry has been somewhat unregulated for so long, numerous industry certifications have emerged. Even after the establishment of GMP in 2007, the importance of these third-party certifications is still quite strong. "

Finding a manufacturer with a facility licensed to produce dietary supplements is "a very good start," says Ung - and, as it happens, Best Formulations is licensed by California Drug, along with GMP certifications from both the Natural Products Association (NPA) and NSF International.

(In Poland it is entry in the register of establishments or entry for approval of the establishment and entry in the register of establishments at the appropriate district sanitary and epidemiological station. You can ask the contract manufacturer of dietary supplements for such a document. An umbrella organization producers of dietary supplements is the National Council of Supplements and Nutrients, members list. [note IOC Sp. z o. o.])

Packaging services

The desire to provide unusual clothing services also goes beyond the basics of production. Providing such amenities has become increasingly popular recently, says Melony Fuller, marketing director at NEC. “Customers want ease of doing business, and we are always looking for innovative and creative ways to provide them with custom solutions that help them succeed.”

Machine for the production of liquid supplements from the supplement production line IOC - supplement production stage

And as more consumers choose to supplement with functional foods and beverages, Bray notes the importance of finding a contract manufacturer who can assist with custom formulation. “We can meet with you and design a blend or granulation specifically for your product specifications,” he says. “We can also help formulate both powdered drink mixes and liquid formulations and then package them in one of our certified facilities in bottles, jars, mason jars or cans with the label on them,” he says.

Be highly analytical

Bray also notes that in an era of increased information transparency, supplement industry companies "cannot hope to compete without new products that have clinical trials to back up their effectiveness." And while some manufacturers will perform this research for you, more often than not, Ung says, the contracting authority takes the lead in selecting the research to undertake, while the contract manufacturer sticks to “making the products for the study, helping to evaluate the scientific validity of the study – if the contract manufacturer has such a capable team – and helping with stability studies, if anything.” -says.

Stability testing has become standard procedure with additives, as the FDA now requires that any direct or indirect references to expiration dates be substantiated by data. This is part and parcel of the analytical emphasis that has moved to the next level with the new GMP requirements. As a result, contract manufacturers offer services covering everything from stability testing to raw material identification and organoleptic evaluations to quantitative testing for heavy metal and microbial composition and content, including total platelet counts, pathogen free and related tests.

Indeed, McNeal believes that "quality control should start as soon as your ingredients arrive in the warehouse." His company begins collecting samples for analysis in both micro and chemical laboratories. “Each raw material is subjected to intensive analysis to ensure its quality,” he continues. “This includes a range of microbiological, chemical identification and other tests.”

Test results should be summarized in certificates of analysis (CofA) for both starting ingredients and finished products, says Akand, “both should be available to the customer.” When it comes to verifying all this, those ordering the production of dietary supplements should “definitely expect guidance on their product's legal compliance” and “any other assistance regarding product quality,” he says.

But don't expect your contract manufacturer to take legal or regulatory responsibility. “When all is said and done,” Bray says, “it is the retailer who is on the box who is responsible for all the information on the label.”

No one is a person without experience

The manufacturer to whom you commission the production of a dietary supplement should also welcome the opportunity to strengthen the business bond between you.

“Listening is the basis of successful relationships,” says Demetrius Bledsoe, Sales Director at NEC. – and technology helps start the discussion. “Social networking sites, websites and customer services make communication with customers more efficient and faster,” he says.

“Customers should have the expectation that a dietary supplement contract manufacturer will work to meet their needs, not the other way around. Every client and project our team works on is seen as important.”

Majeed agrees: there is no such thing as small fry. “Don't forget about the little boys!”, he emphasizes. “Less turnover is always beneficial in almost any economy, especially for startups.”

Although “we don't expect you to become our most important manufacturing client overnight.” - says - “we would like to help and support you to become that person.”

Majeed agrees: there is no such thing as small fry. “Don't forget about the little boys!”, he emphasizes. “Less turnover is always beneficial in almost any economy, especially for startups.”

Although “we don't expect you to become our most important manufacturing client overnight.” - says - “we would like to help and support you to become that person.”

Contract manufacturing in the era of globalism

Nowadays, none of those ordering the production of dietary supplements or producers of dietary supplements on commission can afford isolation. We operate in a global market where brokers and buyers, suppliers and sources are quite far apart. But as Eugene Ung, CEO, Best Formulations (City of Industry, CA), says, “Producing in international markets can be difficult.” Learning to speak the same language “starts with setting the right expectations,” he says.

The process of designing dietary supplements in a pharmaceutical laboratory - one of the processes on machines for the production of dietary supplements

Looking abroad is inevitable in part because global sourcing is "the only way to get most nutrients because there is no country whose home market has all the raw materials," Ung says. But contract manufacturers aren't always experts at navigating international supply chains, he notes, "so it's important to work with reputable and established raw material suppliers who understand the importance of proper documentation and compliance." Don't be afraid to ask for details from the actual producer of the raw material and get references. “The industry is very small and people know each other,” he says, “so ask around and the picture will emerge.”

If you're manufacturing in overseas markets, remember that contract manufacturers who don't have a direct presence in those markets may not fully understand the "ever-changing regulatory requirements of different countries," Ung continues - in this case, "the customer has to be the player to understand international requirements and pass them on to the contract manufacturer,” he says.

Many of its largest domestic market clients are expanding outside the United States, he says, “so understanding these international markets helps our clients. It may be slow and difficult to understand at first, but in the end it can be a rewarding, mutually beneficial opportunity. "

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