Global Sterile Manufacturing Regulatory Guidance Comparison

The publication Global Sterile Manufacturing Regulatory Guidance Comparison: With link to Comparison Spreadsheet compares regulatory guidance documents issued by the U.S. FDA, the EU, the Pharmaceutical Inspection Convention/Scheme and the World Health Organization.

Within the document, you will find analysis and comparison tables that are easy-to-use references for companies that need to adhere to the four regulatory documents; the spreadsheet allows companies to do their own assessment of their status for each element.