NEW Baseline Guide: Sterile Product Manufacturing Facilities 3rd Edition
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. 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.
John Bournas, ISPE CEO and President
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:
- The need to understand product and process requirements
- Use of risk-based approaches
- Role of barrier and isolator technology
- Use of consistent terminology for classified environments
- Categories for processing (open versus closed)
- An integrated facility design approach
Updates to this new edition include:
- Global facility design approach with examples of RABS, full isolator, and BFS recommended layouts
- Harmonized area classifications
- Additional details about local protection/Grade A air supply and particulate monitoring
ISPE will be showcasing the newly released, ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) at their exhibit during INTERPHEX 2018. Purchasers can also access their guide via ISPE’s new Guidance Documents Portal.