Best Practices for Technology Transfer of Sterile Products: Case Studies

Abstract

Technology transfer of products, processes, and testing methods is a way of life in the pharmaceutical industry. Transfer is the movement of knowledge from an originating team and site to enable a receiving team and site to perform the manufacturing, testing, and releasing of the final pharmaceutical product. This includes the manufacture of the active pharmaceutical ingredient, the manufacture of the drug product, and the execution of all the tests associated with the quality assurance of these materials. The case studies discussed in this chapter are based on actual incidences that have occurred in various technical transfer activities. From receipt of excipients and characterization of drug substance to documentation preparation, clarification of compounding and lyophilization steps, to release testing of finished drug product, these case studies provide insight into the types of areas and weaknesses that can arise during the transfer processes, providing clear solutions in upfront communication to avoid such issues during a technology transfer.