ISPE releases Technology Transfer Guide
The International Society for Pharmaceutical Engineering (ISPE) has released its newest technical publication, the ISPE Good Practice Guide: Technology Transfer.
The International Society for Pharmaceutical Engineering (ISPE) has released its newest technical publication, the ISPE Good Practice Guide: Technology Transfer.
The Technology Transfer Guide is a user-friendly manual that presents a clear and concise standardised process for transferring technology between two parties and recommends a minimum base of documentation in support of the transfer request.
The Guide is divided into three segments: Active Pharmaceutical Ingredients (APIs), Dosage Forms, and Analytical Methods, and provides guidance and insight into the essential activities and documentation required to move a product, process or method from one unit to another. The Guide is equally applicable to ethical and generic products, as well as technologies originating from any region around the world.
It is available in soft cover and on CD-ROM and is published in collaboration with the US FDA, European regulatory authorities including the Medicines & Healthcare Products Regulatory Agency (MHRA), Health Canada, the American Association of Pharmaceutical Scientists (AAPS), and the Japanese Society of Pharmaceutical Machinery and Engineering (JSPME).