1. What are your capabilities?
When it comes to capabilities, you want to know a manufacturer can handle your specific needs. If you want to delineate the manufacturers that can handle your project from those telling you that they can, see just how detailed their team can get when discussing their capabilities.
Does the Manufacturer have the ability to create:
• Enteric-coated color-coded formulations?
• Quick release type formulas?
• Sustain-release type formulas?
• Multiple sizes from small to large?
• Herbal formulas?
• Formulas that contain vitamins, minerals, amino acids or any combination thereof?
• Can they handle formulas from the small size of #0 up to #3?
• Are they flexible enough to produce vegetarian, pullulan, gelatin and even extended release (DR) capsules?
• Can they handle formulations that are botanical or vitamin?
• Protein-type formulations, derived from whey, soy or plant-based?
• Can they perform complex flavor masking and/or enhancing?
• Do they even do packaging?
• Are there a variety of options available?
• Multiple sizes of bottles, jars, pouches, blister cards and stick packs?
2. How is your quality controlled?
When talking about quality in contract manufacturing, there are two components to keep in mind: quality control and quality assurance. Control ensures your formulations are meeting specifications, while assurance is dedicated to building quality into your products.
Quality Control -
A quality control team is typically made up of graduate chemists, biochemists and microbiologists. When speaking with a prospective manufacturer, ask about their QC team. Identify education, years of experience and the different types of testing.
Some of the tests they should be utilizing are:
• FTIR testing to identify organic materials
• Thin layer chromatography to identify components within an herb
• Microscopic techniques to identify the structure of an herb through botanical taxonomy
• HPLC testing to determine different constituents of a compound
• ICP mass specs used for elemental determinations
These validated methods assure that the results of what is being tested are accurate.
Another component to consider: How much of the testing is done in-house as compared to being farmed out? Any tests that are outsourced can require additional time, and therefore, slow down the production process. When manufacturers test in-house, they develop numerous amounts of test methods. An experienced company should have hundreds of documented procedures, but also should be consistently adding to their testing.
Quality Assurance -
The right QC tests and procedures can only occur with the right Quality Assurance team creating the proper SOPs, keeping documents up to date and continually optimizing processes.
You can’t test quality into the product. It needs to be there from the ground up. The specifications need to be there. The right protocols and documentation need to support the process so that the processes are consistent and can be duplicated over multiple orders and personnel. There should be a system of vendor qualification and raw material verification. Online intermittent tests, while production and packaging are in process, should be well-defined and documented. Continuous checks for weights, appearance, and hardness (if it’s a tablet) should always be worked on.
Understanding a company’s emphasis on quality will showcase how a manufacturer measures purity, potency, identity, and strength to meet label specifications.
3. How do you determine if your design for manufacturability is feasible?
Most customers generally know what they want. However, not every formula that looks perfect on paper comes together as smoothly as it’s intended. A good contract manufacturer should staff several specialists who design formulas and understand the intricacies of the raw materials.
The right specialists can identify if a tablet formation is compressible, if a capsule can consistently meet fill weight, or if a powder can blend properly and when applicable, taste good. Having specialists that work with the sales/account representatives to help turn that dream into a reality is the best-case scenario for a project.
Unfortunately, there are cases when a design will not work as intended. If a manufacturer has the experience and knowledge of the materials, they can identify early that there could be some obstacles toward the end goal and explain to you specifically what those are. As the customer, account representative and formulation specialist work together, they can leverage what is feasible to find an alternative that works.
4. How do you communicate both internally and externally?
Any good partnership requires each party to provide value to the other. It’s vital for a manufacturer to be open and upfront from the beginning, because a working relationship in this industry requires a lot of collaboration.
Internally, a lot of different departments are a part of a project. For example, if you look at Paragon’s Proven Process, you’ll see all the steps included in a turnkey operation. That requires great teamwork and communication from your manufacturer to ensure each part of the process is done effectively.
Externally, expect to hear a lot of clichés. “We overcommunicate with our clients! We hold your hand every step of the way!” As a customer, the focus should be more into what the collaboration looks like. Follow-up with questions like, “What role does each party play in design formulation? How do you explain unforeseeable obstacles and work through them? How do you tell customers that a product may not be possible?” The key to look for is how specific their answers are. Specificity in the manufacturing of dietary supplements is the glue to a great project. If a numeric value is off, you may not meet label claim. If a deadline is missed, you may not get your order in time.
Make sure communications are thorough and heavy on the details.
5. What is your time delivery percentage?
Always ask this question, and pay close attention to the answer, because it is more of an honesty assessment than anything else. With many outside variables that may be beyond a manufacturer’s control, no one can promise you 100% on-time delivery with every order. There are circumstances beyond the control of the contract manufacturer: material shortages, delays in shipping, importation and custom holds, all of which need to be addressed as efficiently as possible. This goes back to communication and keeping it honest and specific. Everyone wants a 10 to 12 week start-to-finish turnaround. If it’s explained early on where potential challenges can push back deadlines, then customers will know what to expect. They will also be aware that their approval timeline can lengthen the process. If the artwork takes awhile or label approval lags, the project can be delayed.
While the obstacles above cannot be ignored, you do want to ensure your contract manufacturer is timely and committed to hitting deadlines. Ask them why the last three projects that finished on time went so smooth and why the last three projects that did not hit the mark were delayed. The answers to these questions should give you comfort in how your project will be approached and ultimately handled.
6. What accreditations do you hold?
Accreditations are like diplomas, the affirmation and unbiased auditing to measure the quality of a company. If a manufacturer discusses their quality as a differentiator, a natural follow-up is to investigate the accreditations.
Remember that accreditations are hard work and take a long time to get. If the contract manufacturer you’re looking to work with is double or even triple-certified, it’s not some piece of paper that gets handed out to all applicants. It is the result of a commitment to quality and one that never goes away. Paragon is being audited at least once a quarter. These independent bodies consistently review our work. Unlike diplomas, the accreditations do not mean we “graduate” and are finished. It means we’ve reached a level of quality that we intend to stay at.
7. What is your overall track record?
Scaling goes two ways. As a customer, you want to know that your contract manufacturer can handle your growth, and an easy indicator is to see how the company itself has grown over time. Assuming they have been in business for at least 10 years, ask about the changes they have endured over the past decade – what accreditations have been added? What capabilities exist now that did not then? What equipment improvements have they implemented? How much staff has been added?
Reviewing how a company has grown in the last decade is a good indicator of their business development, but don’t sleep on making sure they’ve grown the right way. Ask around and speak to the trade associations and other people in the industry. Look out for warning letters from the FDA. This is an indicator that an organization has had issues that were not addressed properly. You can find these on the official FDA website.
Finding the right contract manufacturer for your business can be challenging. But if you can find a company with:
• the capabilities to handle your project today and tomorrow,
• who invests in quality and can dissect what that means,
• communicates honestly and specifically with you,
• can feasibly design your formulation,
• speaks candidly about on-time delivery,
• has an impressive set of accreditations, and
• has a positive track record clear of violations,
Then you’ve probably got the makings of a great long-term partnership.
If you’re looking to learn more about how the right partner can help you grow – and protect – your brand, we’re always available to chat at 1 (800) 231-3670 or email us at firstname.lastname@example.org.