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.

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.