Partnering with a GMP-compliant contract manufacturer of dietary supplement products is an undertaking not to be taken lightly. This decision has a deep influence on the future success and reputation of your business. Even if your company only packages, labels and/or holds and distributes products, the U.S. FDA requires that you can trace your materials back through a compliant process and to reliable sources.

Before starting the process, it is advised to establish goals internally for product focus, compliance and certification, as well as branding and reputation factors. Setting specifications for what your ideal contract manufacturer should exemplify is a great place to begin. Performing a self-assessment before entrusting an outside production team ensures a more objective view and helps define what is most important to your team. The initial questions that need to be considered are basic in nature, but require considerable thought.

Top Considerations
Location: Overseas or down the road? Determine how important it is that the product be manufactured in the U.S. Today’s educated customers tend to favor products made at home due to strict regulations, as well as the influence of the green movement’s campaign for buying local. Dietary Supplements are regulated by FDA; their manufacture, holding and distribution must follow regulatory laws similar to food, thanks to the Dietary Supplement Health and Education Act (DSHEA).

It is also important to take the company’s headquarters into consideration. If it will be important for the team to visit the manufacturing facility on a regular basis or for yearly audits, consider a contact manufacturer in your area or include plans to relocate headquarters if needed. Other factors to consider in location are the shipping schedules, proximity to raw ingredient suppliers and material shelf lives.  Will your manufacturer have access to the freshest raw ingredients? Will your finished goods be on a ship for two weeks? Would you incur increased pricing due to shipping costs to a reputable lab?

Cost: In running a business, cost must be weighed against factors such as quality, time investment and resulting return on investment. Evaluate how much of your budget is dedicated to manufacturing. How does the contract manufacturer expect to be paid? Does the company have a profit-sharing model? Consider skills, services, business partner introductions or referrals your outfit can provide in return. The cost can also influence the location with regard to business tax rates and local labor costs. It may be more expensive to manufacturer in urban areas compared to a rural location, for example, and moving production overseas can reduce labor costs even further.

Specializations: Manufacturers may specialize in assisting with formulations, may require Master Manufacturing Records to be written ahead of time, or may require production according to internal standard operating procedures (SOPs). Manufacturers might have only certain capabilities. Some may have equipment, staff and SOPs specific to encapsulation of powders, bottling of liquids/tinctures, compression of tablets, extracting botanicals, or infusing oils for geltabs, for example.

Consider the niche market you plan to penetrate, formulator and operator experience as well as plans to expand product lines in the future when choosing a contract manufacturer. Investigate whether a producer could expand to include servicing your future endeavors or whether you are looking for several specialty facilities.

Shade of Green: Are you seeking to establish yourself as an environmentally conscious company? Look into government tax breaks for alternative energy use, and seek contract manufacturers with similar values. Look for a Leadership in Energy & Environmental Design (LEED) certification or if the company identifies as organic, non-GMO and follows Prop 65 guidelines.

With all the political and ethical controversy around these issues, consumers are interested in the background of companies from which they buy products. Savvy consumers search online to see whether manufacturers offset their carbon footprint, donate to hot button causes and support fair trade.

Commitment to Quality
A shared level of commitment to quality between your company and a contract manufacturer is paramount to success. A thorough quality evaluation of a manufacturer involves a Quality Evaluation form (essentially a checklist), review of policies and SOPs, an interview with the manufacturer’s quality team and an on-site inspection. This entails evaluation of the facility, equipment, material controls, training records, SOPs and written or electronic proof that such procedures are always followed without deviation.

Quality Team Interview: Inquire about credentials ahead of time so you can perform your own background check. Ask questions regarding the company’s experience and quality philosophy. It is imperative to ask many questions about the facility, material controls and adherence to regulations with emphasis on what a manufacturer has done in the past.

Inquire about employee, business owner or CEO backgrounds and try to gauge how much GMP experience is behind their work. Ask for training records. Try to understand how important Quality-by-Design or similar values are to the Quality Unit and assess how integral continuous improvements and compliance are to company culture. Inquire about goals set for the future to help evaluate their stance. Request information about internal or third party labs as well.

Quality Evaluation Form: An evaluation form includes general information such as the number of years in business and more specific information, such as storage capabilities and raw-material vendor qualification process. You can find an example of a Quality Evaluation Form at www.GMPCertification.org.

SOPs & Other Documentation: Documentation is proof that procedures are followed and that products are in a controlled state. Thorough documentation can highlight policy effectiveness, quality controls and be invaluable in tracing materials back and forth to batches, whether for improved formulations, deviations, recalls or audits.

SOPs are the backbone of a quality system. Review the policies and SOPs and be sure there are systems in place to track changes. Ensure that SOPs have been signed off with effective dates and ask to see executed records such as batch production records that will provide proof that operators routinely follow SOPs. Look for how deviations and corrective and preventive actions (CAPAs) are handled, and check for cross references, logs for cleaning rooms and equipment, or other data in batch records and testing. Check for test results and certificates of analysis (COAs).

Facilities Inspection: On-site evaluations can provide a complete picture and a real-time snapshot of a potential contract manufacturer. If possible, inspect the manufacturing facility yourself or hire a third party evaluator. Pay close attention to the layout; ask whether the facility was built for GMP manufacturing. Evaluate whether the design facilitates an orderly flow for material movement. Rooms should be labeled and should promote a logical progression of equipment cleaning, storage and use.

Are warehouse, quarantine bins and finished goods clearly marked? Find out if the production suite has been set up in a way that is conducive to quality by requesting details about the process steps. Investigate the controls in place for reducing build-up of dust and microbes by inquiring about cleaning procedures, looking for the absence of nooks and ledges as well as porous materials that may come into contact with ingredients.

The airflow and air quality are also of concern. Check for airlocks and ask about differential pressure and high-efficiency particulate arrestance (HEPA) filters. Take care to look at tanks, spigots and drains and note if they are labeled and dry. Ask about what grades of water are used in production and how often they are tested.

Additional Proof of GMPs
Although FDA does not recognize third party GMP certifications, a manufacturer that makes this commitment demonstrates its seriousness about quality. Ask if the company has a certification or plans to become certified. Finally, perform due diligence. Be aware there are disreputable certification organizations, so if a manufacturing facility touts a certification, ask for the organization’s name and credentials.

Reviewing past FDA inspections and third-party audits will also provide insight. FDA citations, 483s and warning letters are public documents that can be found easily online. You can garner insight by evaluating whether a manufacturer addressed citations in a timely manner and if the FDA was satisfied with the response. A company with goals for making quality products will more likely be enthusiastic about changes and offer plans for the future. Ask for references, but also do your own research to locate other dietary supplement companies working with the contract manufacturer. Ask for their honest opinion on the manufacturer’s performance—good and bad. Remember that no manufacturer will be perfect. 

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Dr. Richard Soltero has more than 40 years of R&D experience in pharmaceuticals, OTCs and dietary supplements. Prior to founding InstantGMP in 2004, he held several executive positions at well-known pharmaceutical companies. InstantGMP develops electronic batch record software and SOPs that reinforce GMPs for the dietary supplement industry.