In the drug development process, time to market, billions in IP investments, and most importantly, human lives are at stake. One of the greatest challenges of the process is ensuring that documentation is complete, accurate and carefully controlled in accordance with each phase of the drug’s lifecycle.
In my previous blog, I discussed the challenges of the technical transfer process. The technical transfer process is a systematic procedure that is followed to pass the knowledge and experience gained during development to the parties who will assume responsibility for commercial production of the product.
I described this process as often not discernible to virtual and geographically dispersed teams but a critical juncture in bringing safe, effective drugs to market. Because smaller quantities of drugs are manufactured to support the clinical trial process, organizations must ensure that the manufacturing process consistently adheres to defined specifications and acceptance criteria as scale up production occurs and the competency of the manufacturing site is evaluated.
Documentation is not only germane to this process, but once the documentation is transferred from R&D to manufacturing; new Good Manufacturing Practices Regulations (GMP) go into effect. This documentation continues to be revised and updated throughout the drug lifecycle and is intrinsically linked with R&D because when changes are proposed, they may require a re-submission to regulatory authorities.
So what can organizations do to streamline and automate this process to ensure an expeditious transition? Is there a way to facilitate better communication between R&D and quality and manufacturing as the documentation is updated and revised over time?
Five Goals to Strive For to Improve the Technical Transfer Process
1) A Single Source of Regulated Content: The transfer of technology is accomplished primarily through written protocols and reports that can leave room for misinterpretation. This misinterpretation can be due to an inconsistent use of vocabulary across groups or disconnected sets of information that reside in system silos but which need to be shared holistically as part of the technical transfer process.