Captek Softgel International

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Healthy “Working” Partnership with Your Manufacturer?

Business Partners

Brand Owners, Do You Have a Healthy “Working” Partnership with Your Manufacturer?

What are the key elements of a successful brand owner/manufacturer relationship today? Whether you prefer a master agreement, a less formal contract, or signing a simplified PO – one thing must prevail –  detailed and timely communication between the two parties before, during, and after product runs.

Both sides of the production line are vested in ensuring safe and profitable products go to market. Mutual buy-in as to who is responsible for what is key to creating a positive business relationship and to supporting an ongoing environment which lends itself to repeat business partnering.

Brand owners have to qualify their contract manufacturers just as much as manufacturers have to follow vendor qualification programs. Each link within the supply chain has the responsibility to qualify the previous component. Today with the globalization of our industry in which there are so many different links, so many dimensions within the chain – if you don’t qualify your upstream and as deeply as possible, then you run the risk of not ensuring the identity, purity, strength, and composition of your products. In healthy, successful partnerships, every effort and action item works in tandem towards that end.  

Speaking from Captek’s perspective, Vice President of Quality and Regulatory, Paul Hwang, says the big attraction and appeal that a company like Captek offers to brand owners, large and small, is their advanced knowledge and expert ability to create and successfully engineer complex formulas using hundreds, if not thousands, of uniquely different raw materials into a softgel. He explains that the robustness of their material qualification program is at the heart of what makes them a sought after custom manufacturer.  

“We are detailed and process oriented:  from following documentation requirements such as detailed vendor qualification protocols, material safety data sheets, to following manufacturing flow charts, and guidelines of our distributor qualification program. Being a good partner is also knowing when to say ‘no’ to a brand owner when it’s in the best interest of the end-users. Decisions must be made if it’s even feasible to put certain ingredients into a softgel.”

What makes a good partnership is true understanding of what is desired in balance with what is deliverable. So many problems can be avoided if the distributor visits the manufacturing facility before commitments are made. Representatives can meet with QA, QC, R+D, plant management team members, review documentation, spell out expectations of product specs, nail down quote details, and see first-hand exactly how their “prospective partner” runs their operation from beginning to end. Batch runs can be observed and where product is warehoused after it comes off the production line.

By taking time to visit on-site, brand owners can also:

More clearly assess the manufacturer’s priorities and culture
Evaluate training and expertise of production and laboratory staff
Review contract manufacturer’s standard operating procedures
Establish an atmosphere of openness and convey top business priorities
Discuss specific GMPs to be followed and resulting expectations
Come to agreement on scope of work and who is responsible for what

Time is well spent reviewing: formula rights, registrations, COAs, specific equipment to be used, exact types of tests to be conducted, who to communicate to about changes, how components are to be sourced and verified, labeling inspections, disposition outcomes, access of records, sample retains. Meeting on-site gives brand owners an opportunity to directly address and clear up any items they may have on their checklist of concerns.

We all know the maze of requirements can be daunting. If you’re working with a manufacturer that requires adherence to an extensive pre- and post-production testing/documentation process – that’s a good indicator. It demonstrates they know the law and are a partner of integrity. Putting controls in place and following GMPs prevent quality problems; they assure that the amounts of ingredients printed on the label are what is actually in the bottle – no more, no less. Captek’s CEO, David Wood, believes the manufacturer and the brand owner benefit from extensive evaluation and documentation, as it protects both parties down the line if anything is questioned.  

He emphasizes, “We are known in the industry for our proactivity to ensure our customers’ products are protected. We perform critical evaluation for the specs for individual test attributes and the justification for why each attribute and specifications are uniquely established the way they are – that level of commitment and attention to detail translates to a custom shop. So, in the end, what we deliver is customized to the unique requirements of the finished product strictly adhering to all FDA regulations”

Most of the manufacturers and brand owners who have demonstrated longevity in the dietary supplement business don’t flourish by one-time transactions. The goal should be building, preserving, and fostering ongoing business collaborations. Long-lasting, mutually beneficial partnerships consistently start and end with clear and frequent communication.

Source:  www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm