On Thursday, April 21, 2016, Sentry BioPharma Services completed a self-directed (voluntary) inspection of the company’s foreign trade zone (FTZ) and compliance with 15 CFR Part 400. Randall L. Higgins, Sentry’s Senior Manager of Compliance and Validation, defines five main benefits of an independent compliance evaluation as follows:
Establishes a Professional Relationship
Sentry BioPharma Services establishes a professional relationship with an experienced and specialized service provider for several reasons. Familiarization with Sentry’s organization, employees, facility layout, policies, procedures, daily activity and compliance history facilitates the uptake of tacit knowledge. Clear communication channels streamline response time when trouble-shooting a problem or developing a new business opportunity. Having an established relationship also creates a new avenue for gaining important information and insight, which is especially important as new regulations evolve.
Builds Regulatory Alignment
Tapping the knowledge and experience of a foreign trade zone expert helps a company build stringent alignment with requirements of various regulatory agencies (DEA, FDA & CBP). Normally, the specialized consultant starts with an unbiased gap analysis to test the company’s system for robustness. This analysis offers a realistic picture of the present state of affairs. It also simulates the way a regulatory agency may conduct an impromptu CBP inspection. The non-threatening environment fosters collaboration to proactively reveal unknown deficiencies and opportunities for improvement.
Drives a Competitive Advantage
Teaming up with a foreign trade zone specialist serves as a competitive advantage. The FTZ consultant identifies operational inefficiencies and offers suggestions to improve routine and in some cases repetitive tasks. The import/export professional advice can lead to the elimination of non-value added tasks, simplification of paperwork and the reduction of redundancies. In some cases, the objective analysis minimizes or eliminates duties, processing fees, violations, fines and penalties.
Cooperates with Administrator of the Grant of Authority
Sentry BioPharma Services’ FTZ is part of Zone 72 and is identified as subzone 011. Sentry’s zone is located at the Indianapolis International Airport (IND) and is not considered within the customs territory of the United States. Sentry intends to continue participation in the Federal Foreign Trade Zone program for years to come. By voluntarily completing an internal FTZ system audit, it demonstrates Sentry’s intent to maintain a good compliance record year-after-year with its grantee.
Cultivates New Business Opportunities
The advice of a foreign trade zone consultant typically brings solutions to pain points in the pharmaceutical supply chain. In many cases, unique problems serve as opportunities to grow the business and expand the service offering. Clients with temperature-sensitive pharmaceutical products are often looking for ways to better control the pharmaceutical supply chain. Protecting pharmaceutical product integrity tops the list. Also high on the list of client needs are expediting shipping and/or customs clearance requests. Customers benefit from the added level of drug product protection which results in time-saving and overarching risk mitigation.
Mr. Randy Higgins expands, “Sentry BioPharma Services has delivered a pristine regulatory compliance record to existing and prospective clients’ year-after-year. By embracing self-directed and independent evaluations, Sentry protects the safety, identity, strength, purity and quality (SISPQ) of the pharmaceutical products and controlled substances moving through our GMP warehouse on a daily basis.”
Sentry’s active FTZ status and customs bond support import optimization and control of temperature-sensitive biological and pharmaceutical ingredients, materials, semi-finished and finished drug products. For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import process, contact Sentry via email or by phone at 1-866-757-7400.