ISPE Good Practice Guide: Technology Transfer

In many cases, the cost and time required to transfer technology has risen due to inconsistent interpretation of regulatory requirements. Avoid these pitfalls by ordering your copy of the ISPE Good Practice Guide: Technology Transfer today.

The ISPE Good Practice Guide: Technology Transfer is a user-friendly manual that presents a clear and concise standardized 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.

The Guide is very useful from the earliest phase in a product’s life cycle to post-approval transfers 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.

Drawing from a consortium of worldwide expertise, ISPE has published the Guide in collaboration with the US Food and Drug Administration (FDA) and the American Association of Pharmaceutical Scientists (AAPS), with input from the European regulatory authorities and submission to the Japanese Ministry of Health and Welfare (MHW).

Published:

03/01/2003

ISBN(s):

1931879133

Number of Pages:

128