DESIGN & IMPLEMENTATION OF A NOVEL PACKAGING COMPONENT PROCESS. KJ Patten, JM Dierolf. Merck, Whitehouse Station, NJ
The pharmaceutical industry continues to advance by developing new and innovative methods to improve dosing techniques or aid in patient dosing as well as modifying dosage forms to meet patient needs. In many cases new container closure systems are required to support the manufacturing, packaging, distribution, dispensing or administration of these drug products. With the industry moving in this direction the need arises to develop and approve these novel packaging components in support of a particular clinical trial or pharmaceutical product under development. The goal of this project was to develop and implement a process to create development specifications for these novel packaging components to support release for use in clinical trials. The process was designed using basic quality by design (QbD) principles focusing on identifying critical quality attributes of the drug product and defining functional requirements of the novel packaging components while assuring product efficacy and patient safety. The process was implemented under the development of a standard operation procedure which identifies the requirements to receive and release novel packaging components used in clinical trials. The process is focused on the creation of a packaging component development specifications which identify the release testing requirements unique for each novel packaging component, the acceptance criteria for each test and the method of testing with emphasis on BSE/TSE compliance. To date several different types of novel packaging components have been released using this process for use in clinical trials to support the advancement of the pharmaceutical industry.
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