They can safeguard supply by producing at more than one site, and improve distribution by moving production closer to critical markets. They can also reduce programme costs and risks by moving production to sites that are better qualified, can produce more economically or are better positioned to meet the needs of regulators.
However, for several reasons, transferring production — and the technologies that support it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections; staff at a receiving facility may not have the proper technical skills to execute a specific process; or there may simply not be enough trained staff on site to ensure that the job will be done correctly. Also, even as companies may not take the time (or expend the effort) to create and provide good documentation of their product or process, their partners may not invest the necessary resources to ensure efficiency and quality.
If any of the above occurs, time and money will be lost in remediation and patients may not receive their medication. The net result of these risks is that companies do not transfer production as often as they probably should. However, Patheon has a great deal of experience in technology transfers and has developed processes and techniques to reap its rewards while reducing its risks.
Not yet a Subscriber?
This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Manufacturing Chemist.
Subscribe now Already a subscriber? Sign in here.