Issue link: https://www.e-digitaleditions.com/i/819216
48 May 2017 Tablets & Capsules Most countries, the USA among them, have either a regulatory roadmap in place or have already implemented pharmaceutical serial- ization. Whatever their status, the goal is the same: to protect pharma- ceutical supply chains against crimi- nal activity, improve efficiency, and safeguard patient health. The US mandate for serialization appears in the Drug Supply Chain Security Act (DSCSA), which requires pharmaceutical companies to "serialize" all prescription drug prod- ucts intended for distribution in the USA. That means each carton, tray, bottle, and case must bear a unique identifier. The deadline is November 27, and violation of the law could trigger fines and other penalties. In the European Union, the Falsified Medicines Directive requires companies to provide unit-level seri- alization and dispenser authentica- tion by February 2019. In India, the Directorate General of Foreign Trade has mandated serialization of sec- ondary and tertiary materials and set guidelines for reporting exports. Because India is a major exporter to the USA, Europe, and other markets, these regulations will have a signifi- cant impact. Other countries have similar regulations. It's late, so don't wait Needless to say, establishing a compliant serialization process is a major undertaking. For some compa- nies, it involves multiple locations and packaging lines, each equipped with serialization software and hardware to meet different regulations around the globe. Implementing serialization starts with upgrading the packaging line with new equipment and modify- ing the Risk Evaluation and Mitigation Strategy (REMS) strategy. With the US deadline nearing, lead times for serialization equipment have grown longer and many pack- aging and data experts are booked. If you haven't already begun, you need to act now. Don't wait. Here are some steps to take: Form a serialization team. Make it a cross-functional group of the best employees involved in packag- ing and labeling, manufacturing, supply chain management, engineer- ing, IT, regulatory affairs, business strategy, and finance. The team's charter is to meet the serialization requirement, ensure GMP is upheld, and protect the business. Assess the project scope. The team must identify stakeholders. It must also assess how business constraints could help or hinder compliance with DSCSA. Find out what exactly needs doing and how fast it can be done. The deadlines are no longer distant or uncertain. Focus. Make sure everyone understands the importance and scale of this undertaking. Set boundaries. Since a project statement doesn't enumerate all the goals and constraints, list those objec- tives so you fine-tune your aim. Each objective should be clearly and con- cisely stated and measureable. Establish standards of performance and monitor your work to see whether you're meeting the benchmarks. Plan for action. You've it heard before: "Plan the work, and work the plan," and it's still good advice. Ensure the plan you establish addresses all aspects of the project. Serialization isn't just about changing packaging lines or upgrading the ERP. You need to assess many components, ranging from the readiness of the ERP system to serve as the master data repository to changes in artwork for all affected SKUs. You will probably need an enterprise serial- ization manager. The goal is to estab- lish an integrated system architecture that ensures information flows to and across all components. Check for compatibility. Because your company works with a variety of trading partners, you'll need to imple- ment the Electronic Product Code Information Services (EPCIS) GS1 Standard. This enables you to create event data and share it with con- tracted partners to improve visibility and ensure interoperability of the data. This is called "supply chain mas- ter data" and it provides information about the products, company, and locations. You need to use this stan- dard to gain real-time visibility and exchange serialization information. Invest in training. As packaging equipment is upgraded and SOPs are updated, the work flow will change. Make time to train the technicians and operators. That will be critical to your success. The overriding objective is to make every tablet, capsule, and blis- ter pack traceable through the phar- maceutical supply chain. Serialization is the first stage of developing a sys- tem that will reduce counterfeit, stolen, and contaminated drug prod- ucts, protecting consumers and your business. T&C Michael L. Keech is head of business strat- egy at Lachman Con- sultants, 1600 Stew- a r t A v e n u e , S u i t e 604, Westbury, NY 11590. Tel. 516 222 6222. Website: www.lachmanconsultants.com. Keech provides strategic and tactical guidance on regulatory requirements and compliant solutions involving the clinical and com- mercial manufacture/control for pharma- ceutical, biopharmaceutical, and medical device companies. b a c k p a g e Serialization: Too late to start?