Guides

Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance. They typically focus on the “what”, but may also provide some information on implementation.

Language
English
Guidance Docs
Thisguide provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations.
Guidance Docs
The ISPE Guide: Biopharmaceutical Process Development and Manufacturing focuses on the development and the process approaches and practices involved in providing cost effective, regulated manufacturing of biopharmaceutical products in a timely manner that meet their intended use.