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ISPE Releases Updated Sterile-Product Manufacturing Baseline® Guide

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ISPE, has announced that it will soon release an update for its ISPE Baseline® Guide: Sterile-Product Manufacturing Facilities (Second Edition).

This update, which is intended to replace the original Guide, integrates and consolidates international practical solutions that address sterile manufacturing technological advances since the original Guide’s release.

“When the original Guide was released in 1999, it met a need in the marketplace by providing a comprehensive resource to help interpret and implement FDA regulations with respect to design and operations used for the manufacture of sterile pharmaceutical products,” said Bruce Davis, leader of the team responsible for the Guide update.

Davis continued, “However, as technology advanced, aseptic processing in manned cleanrooms was no longer considered current GMP and ISPE began tracking and communicating new, better methods of sterile manufacturing design. What’s great about the new update is that it consolidates all of ISPE’s latest best practice recommendations on sterile manufacturing facility design into one document.”

The updated Baseline Guide is a complete revision of the original version, and contains recommendations to help facilitate compliance with the latest FDA and EMA guidance.

The update is aimed at a truly international audience, as it incorporates a comprehensive tabulation, explanation, and comparison of the cleanliness designations found in FDA, EMA, and ISO guidance documents, allowing for better harmonization in global facility design and a wider breadth of regulatory compliance internationally.

Technical updates contained in the Guide include the use of RABS and isolator technology; facility design; best practices for terminally sterilized and aseptically processed sterile products; and updated guidance on quality attributes of construction and finishes solutions for different grades of facility.

The Guide includes informative diagrams and thorough text to explain and compare GMP requirements, providing a platform for developing compliant solutions and allowing firms to follow several different routes to reach a compliant solution.