The guide aims to offer a consistent interpretation of the latest FDA and EMA guidance.
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, CEO and President, ISPE. “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) focusses 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
- Harmonised area classifications
- Additional details about local protection/ Grade A air supply and particulate monitoring
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