Issue link: https://www.e-digitaleditions.com/i/507774
Tablets & Capsules May 2015 9 from the time the product is produced, packaged, and labeled to its ultimate distribution—requires special care in terms of product shelf life, temperature control, storage, and shipping. From a regulatory standpoint, different gov- ernments take different views of drug products, their com- ponents, and how they must be handled and documented. Using a contract packager Contract packagers allow pharmaceutical companies to focus on their core competencies of developing and marketing needed drugs. When identifying the right con- tract packager, pharmaceutical companies need to con- sider compliance, capacity, and capabilities. There are many contract packagers to choose from. According to a 2013 technical market research report, the global market for pharmaceutical and biopharmaceutical contract man- ufacturing, research, and packaging was valued at $219.9 billion in 2012 and is expected to reach nearly $374.8 billion by 2018, which equals an annual growth rate of more than 9 percent [2]. Outsourcing packaging is a beneficial business strategy because it enables pharmaceutical manufacturers to transfer non-core activities to external partners, allowing manufac- turers to restructure their distribution networks, make bet- ter use of internal resources, and intensify their focus on research and development. Meanwhile, contract pharma- ceutical packagers can focus on incorporating packaging innovations, which "are expected to create a major change in the way drugs will be packaged," according to a 2014 report form Frost & Sullivan [3]. In many cases, outsourc- ing has improved supply chain management; it can also reduce total supply chain costs by 25 to 50 percent [4]. Serialization The most critical issue today for people working in the pharmaceutical supply chain is serialization, also known as track and trace. It's an area that continues to grow to fight drug counterfeiting, which is a multibillion-dollar industry. While its exact extent is unknown, in some areas of Asia, Africa, and Latin America, counterfeit medical goods constitute as much as 30 percent of the market, according to Interpol. In a single operation last year, its agents seized 9.4 million doses of fake medicines [5]. By 2018, track-and-trace regulations—including the Drug Supply Chain Security Act (DSCSA) in the USA— in the EU, China, Brazil, Korea, and Argentina, and other countries will be in force and apply to more than 75 per- cent of global medicines. Already in January 2015, more than 20 markets have in place or have pending pharma- ceutical serialization requirements [6]. Instituting serial- ization, product tracing, product verification, and gov- ernment reporting systems that comply with all these requirements is a complex undertaking, and the risk of missteps is high. What to look for in a serialization and contract packaging partner Every pharmaceutical company should be studying how it will meet serialization requirements, especially those with global reach. Today, serialization is front and center as the means to ensure the quality and safety of drug products as they move through the supply chain. Make sure the contract packagers you consider are well versed in that area. They should also understand bright- stock labeling, which can help streamline drug product distribution in countries beyond where the drug product was manufactured. Every contract packager under consid- eration should also offer production flexibility in terms of packaging lines that can handle a variety of products and batch sizes. Whenever drug products are shipped internationally, government agencies must be confident that you're ship- ping exactly what you claim. That minimizes the risk of contamination and counterfeits, thereby promoting qual- ity and patient safety. When the DSCSA became law in November 2013, it tasked the FDA with developing a means of tracking drug products throughout the supply chain. To that end, all pharmaceutical companies must add serial numbers to their packages in the next 4 years. Package labels must be upgraded to electronic codes by 2023 so that ownership can be traced to the original manufacturer or repackager. Pharmaceutical companies should ensure that their contract packagers have a complete serialization program in place, one that tracks a given product's chain of cus- tody from the manufacturer to the point of dispensing and securely stores that history, known as an e-pedigree. Additionally, the e-pedigree should provide data about the batch from which the drug product was manufac- tured. That means contract packagers should affix a unique and traceable serialized number to every package, Seek a contract packager that can handle large and small batches and whose equipment can package drug products in different formats.