Issue link: https://www.e-digitaleditions.com/i/507774
bundle, case, and pallet associated with that drug prod- uct. That way, at each leg of the product's journey from the manufacturer to the consumer, the serial number can be scanned and added to a database in order to document the product's official chain of custody. These standards, used mainly to reduce counterfeiting, require that con- tract packagers understand how the requirements differ, often subtly, from country to country. No matter where you plan to sell your products, every contract packager you consider should offer flexible pro- duction. That means operating several lines that run your product, not just one. It also means the company's equip- ment should handle large and small batches and adapt easily to package your drug products in different formats. There are several additional factors to consider: Project management. Ask the contract packager to describe its project management system in terms of who is handling your project, the expected turnaround time, and whether there will be a line dedicated to your product's run for as long as it's needed. Look for a plan that defines the requirements of each new project and describes how they will be met. Ideally, project management includes team planning and weekly or bi-weekly meetings. Packager profile and history. Look at the experience of the management group and the team's knowledge. Its employees should be confident in what they propose and should back up their proposals with documentation. Can the group provide turnkey solutions under one roof? That typically provides tighter control over the supply chain. How long has the packager been in business? Regulatory capabilities and track record. Ask about FDA audits and how the contract packager performed. Find out when the last audit occurred, whether the site complies with current GMP, and if any 483s (warning let- ters) have ever been issued. If the company is involved in packaging dietary supplements, check its regulatory sta- tus. You need to know that the company has undergone an FDA audit and is registered with the DEA to handle your pharmaceutical products. Dedicated resources. Depending on how many lots you anticipate running, the packager should be able to tell you whether they have the equipment and tools needed to produce your product and manage your pro- ject. Verify it during a plant visit. Rest-of-world packaging and bright-stock labeling Contract packagers can also help pharmaceutical com- panies extend the reach of their new drug products by helping them comply with the regulations in markets out- side of the USA, Europe, and Japan. This can be done using the rest-of-world (RoW) packaging concept. With RoW, products specific to the country in which they will be consumed are held in inventory and, as needed, the contract packager labels the goods with the required information in the correct language. It's similar to the concept of bright-stock labeling. In fact, the practice of labeling products immediately after manufacture is disappearing. More often, drug prod- ucts are manufactured in large batches and stored in unla- beled primary containers that bear only expiration dates and tracking information. These containers then receive compliant labeling in the language appropriate to their destination just prior to shipment. This is called bright- stock labeling and it's beneficial to manufacturers of pre- scription and over-the-counter products because it allows companies to operate on a "just-in-time" or "made-to- order" basis, typically in cooperation with a contract packaging company that maintains the manufacturer's inventory. (The term "bright stock" comes from the food industry, where it referred to metal cans of vegetables, soup, or other products that had yet to be labeled.) Using the bright-stock approach, a US-based contract packager might receive filled and capped bottles of tablets from Europe and simply add a label and insert that suit the 10 May 2015 Tablets & Capsules A marshalling device transfers completed blisters to the conveyor for further packaging. The practice of labeling products immediately after manufacture is disappearing. More often, the package bears only an expiration date and tracking info until just prior to shipment, when compliant language is added.