Natural Products Insider

JAN-FEB 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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32 INSIDER January/February 2018 manufacturer, and open themselves to liability by not having a strong quality system to release products to the market. INSIDER: What should be outlined in a contract with a contract manufacturer? Finamore: These contracts establish responsibilities, but need the fl exibility to grow and be modifi ed as the relationship changes. While basic GMP requirements remain static, as a business relationship matures and, as regulations/industry practices are modifi ed, all agreements must be designed to grow with the relationship so they do not become forgotten or obsolete to the detriment of both parties. LeDoux: Contracts should be of suffi cient length and value to ensure the contract manufacturer is permitted to recoup capital costs associated with creating processes specifi c to the brand owner's needs. Of course, failure to meet the requirements of a contract should also be clear. Continued breaches should be addressed, and mechanisms for voiding the contract should also be listed, along with competent jurisdictional oversight or binding arbitration requirements. Fairman: A key to a successful contract manufacturing partnership involves having a well-written, mutually understood and executed quality agreement and a contract of business. The latter should focus on the terms of payment, delivery, expiry of service and any other major business transactions that are legally binding between the two parties. The quality agreement should clearly refl ect the regulatory responsibilities of both parties in detail of the applicable cGMPs. Akand: A manufacturing supplement agreement should cover the general business terms and conditions. A supply agreement details what the contract manufacturer agrees to provide. A quality agreement with a contract manufacturer is one of the many things an FDA inspector is looking for. Whereas the supply agreement covers the basics of commerce, the quality agreement details responsibilities of the contract manufacturer and supplement brand owner for GMP compliance. INSIDER: What checks or quality assurance (QA) procedures should a brand owner conduct throughout a relationship with its contract manufacturer? Akand: Brand owners need to invest in personnel and quality management systems to supervise and audit the supply chain. Brand owners should frequently and randomly audit their suppliers for GMP compliance. Moreover, brand owners should also conduct thorough batch record reviews of each lot, and use third-party analytical laboratories to ensure product identity, purity, potency and composition. Cusick: A plant tour should occur prior to engaging a contract manufacturer, as well as meetings in person once per year. It is a great way to build a solid foundation for a long-term relationship with the team players. LeDoux: Trust but verify seems to be the course of prudence. A healthy relationship is based on honesty and transparency, and involves constant communication that is direct and unfettered. QA procedures should be centered on evidence of appropriate product testing at all process points that could be considered hazard analysis and critical control points (HACCP), and a positive release system needs to be followed. A recall procedure needs to be agreed upon clearly identifying appropriate steps to protect human health. Fairman: Both the brand owner and contract manufacturer should initially determine and agree upon the frequency of onsite visits/audits to be conducted. During these checks, a general cGMP sanitary inspection of the facility and grounds should be performed, and subsequently, a review of current standard operating procedures (SOPs), test methods and specifi cations relative to the brand owner's products. It is strongly recommended that a mutually open communication and transparency policy is established early in the partnership. Contract Manufacturing: Best Practices Establishing a Successful Contract Manufacturing Partnership Successfully working with a contract manufacturer requires identifying a partner that is the right fi t. Download INSIDER's Digital Magazine to learn more on establishing a formal written agreement and committing to diligent communication throughout the production process. Vol. 7, No. 14 July 2017 US$20.75 Establishing a Successful Contract Manufacturing Partnership SEPTEMBER 25-29 Expo Hall September 27 & 28 Mandalay Bay Las Vegas Scan Here

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