ISPE Baseline Guide: Sterile Product Manufacturing Facilities (Second Edition)

The newly updated ISPE Baseline Guide: Sterile Product Manufacturing Facilities 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.
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