ISPE to Publish Updated Sterile-Product Manufacturing Guide

Sep 15, 2011

The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide, ISPE Baseline Guide: Sterile-Product Manufacturing Facilities, and contain practical information about technological advances in sterile manufacturing.

The updated guide will be a complete revision of the original version and include new information on various topics, including restricted-access barrier systems 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 for various grades of facility. The guide also will include diagrams and detailed text to explain and compare GMP requirements. ISPE intends the new publication to help personnel develop compliant manufacturing solutions and to propose various routes for achieving compliance.

The organization revised the guide with an international audience in mind. The update will tabulate, explain, and compare the cleanliness designations found in guidance documents from FDA, EMA, and the International Organization for Standardization. The guide is intended to improve harmonization in global facility design and foster international regulatory compliance. The new document will include ISPE’s recommendations for complying with the latest FDA and EMA guidance.

“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 update, in a press release. “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,” he added. The update will consolidate all of ISPE’s latest best-practice recommendations on sterile manufacturing facility design.

ISPE is a not-for-profit association of 22,000 pharmaceutical professionals in 90 countries. Members collaborate to provide GMP solutions, and the organization works with global regulatory agencies and industry leaders.


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