Placebo Production for Packaging Trials


A large, multinational pharmaceutical company needed to qualify new packaging equipment designed to improve its operational efficiency and cost structure. To achieve this operational milestone, the client required placebo tablets for multiple product lines to use as part of its qualification process. PGC assisted in this process by manufacturing all the required placebos.


Because the client wanted to use its new packaging equipment for multiple products, the client had distinct specifications concerning the placebos required for testing, including different sizes (from as small as 3/16-inch by 3/16-inch to as large as 3/8-inch by 3/4-inch); different shapes (e.g., round, oval, capsule-shaped, three-sided, four-sided, five-sided and six-sided); with or without a score; and various film coating solutions (i.e., an array of colors, clear films and functional enteric films). Furthermore, the client considered this a priority corporate project, and its executives had to adhere to a tight, demanding schedule. However, the company was running its manufacturing sites at capacity to produce commercial product and did not have excess capacity to produce the placebos itself. Therefore, the client had to look for a strategic contract manufacturer for this project.


PGC collaborated with the client team, consisting of members from quality assurance, quality control, regulatory, manufacturing, materials purchasing and packaging, to develop a comprehensive plan, including details for materials procurement, storage, shipping, transportation and timing, to complete the project. Ultimately, PGC was able to manufacture placebo tablets for 24 different products, ranging from a 500,000 to 1,000,000 tablet quantity for each product. These placebos had to be produced according to client's specification, including thickness (from 1/16-inch to 5/16-inch, which included the film coats) and coating materials. Flexibility and adaptable workflows allowed PGC to deliver these placebo tablets as required, and the client was able to use these placebos to qualify its new packaging equipment.