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
Published: August 2020 Pages: 236 Bound version will ship after 18 September 2020 Table of Contents Special Pricing for Emerging Economies Regulatory agencies expect the development and validation of a compliant cleaning program. This critical
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.