Issue link: https://www.e-digitaleditions.com/i/581434
www.tabletscapsules.com P ackaging P roduction Formulation • Each ingredient and finished product contains the specified concentration of each active ingredient (strength); and • Each supplement contains nothing more and nothing less than what its label states (composition). That said, be careful not to over-specify the terms of your quality agreement too early, because that could box you into rigid and potentially inefficient or impractical specifications. Rather, work out the specifics over time with your co-signatories so that you have a concrete understand- ing of the issues and can make better decisions. Specification templates are handy starting points, but they aren't one-size-fits-all. Consider each specification carefully and whether it's really needed. Challenge boilerplate speci- fications, especially those that have no better rationale than "That's the way we've always done it." More than a handshake At one time a deal between an OLD and a CMO was spelled out in a simple work-for-hire purchase order and sealed with a handshake. Those days are gone. In today's regulatory climate, OLDs must establish a detailed quality agreement with their CMOs that clearly identifies the duties and responsibilities of each partner to ensure FDA compliance. Be ready to demonstrate how you know, and how you can prove you know, that all manufacturing activi- ties comply with cGMP, and be clear with your partners about your expectations. T&C References 1. FDA warning letter, issued to Pristine Bay et al., April 26, 2013. bit.ly/FDAwarnPristine. 2. Federal Register, Volume 72:34752 at 34790. 3. Ibid. at 34790. 4. FDA draft Guidance for Industry: "Contract Manufacturing Arrangements for Drugs: Quality Agreements," May 2013. 5. Ibid., lines 149-164. 6. 21 CFR §111.3. Justin J. Prochnow is an attorney and shareholder in the Denver office of international law firm, Greenberg Traurig, 1200 17th St., Ste. 2400, Denver, CO 80202. Tel. 303 572 6500. E-mail: prochnowjj@gtlaw.com. His practice focuses on regulatory and legal issues affecting the dietary supplement, food and beverage, and cosmetic industries. This article was adapted from a joint presentation delivered by the author and Dean R. Cirotta, president & COO of EAS Consulting Group (Alexandria, VA); Nicki Jacobs, founder, Jacobs Compliance Services (Vista, CA); and David Morrison, vice president of scientific & regulatory affairs, The Vitamin Shoppe (Secaucus, NJ) at the American Conference Institute's 3rd Annual Legal, Regulatory, and Compliance Forum on Dietary Supple- ments, New York, NY, June 24-25, 2015. 32D October 2015 Tablets & Capsules