The Parenteral Drug Association, Inc. (PDA), the leading community for pharmaceutical professionals developing and manufacturing sterile drug products, today announced the publication of Global Sterile Manufacturing Regulatory Guidance Comparison – With link to Comparison Spreadsheet. The document compares regulatory guidance documents issued by the U.S. FDA, the EU, the Pharmaceutical Inspection Convention/Scheme, and the World Health Organization.
PDA’s Global Sterile Task Force, comprised of experts from leading pharmaceutical companies, carefully and thoroughly pored over each sentence of these guidances and developed an extensive comparison of each element. The team then conducted an extensive analysis of the commonalities and differences in the four documents.
“The task force has done a great service for industry by producing this first-of-its kind document, which was reviewed and approved by PDA’s Regulatory Affairs and Quality Advisory Board and Board of Directors,” said PDA President Richard Johnson. “The analysis and comparison table are easy-to-use references for companies that need to adhere to the four regulatory documents. The spreadsheet is a tool which allows companies to do their own assessment of their status for each element.”
Global Sterile Manufacturing Regulatory Guidance Comparison – With link to Comparison Spreadsheet is available to PDA members and nonmembers at the PDA Bookstore.
The publication includes a link to the Microsoft Excel® spreadsheet.