This publication provides guidance on engineering facets of designing new sterile products manufacturing facilities and modifications of existing facilities.
BETHESDA, Md. (PRWEB) April 16, 2018
The International Society for Pharmaceutical Engineering (ISPE) announced the release of their latest Guide, ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition). This publication provides guidance on engineering facets of designing new sterile products manufacturing facilities and modifications of existing facilities.
“Understanding regulatory compliance is a challenging feat, one that can impact technological advancement and increase operational costs,” said John Bournas, ISPE CEO and President. “This guide aims to offer a consistent interpretation of the latest FDA and EMA guidance, while allowing a flexible and innovative approach to facility design.”
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) focuses on best practices for an approach that is effective, cost-efficient, and in compliance with the latest FDA and European Medicines Agency (EMA) guidance. The guide is based on key principles, including:
Updates to this new edition include:
ISPE will be showcasing the newly released, ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) at their exhibit during INTERPHEX 2018. Find the new guide at http://www.ISPE.org/Publications/Guidance-Documents. Purchasers can also access their guide via ISPE’s new Guidance Document Portal.
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.
For more information, contact:
Maria Robertson
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1-301-364-9207
Email: mrobertson@ispe.org
http://www.ISPE.org