Electronic document includes link to a customisable spreadsheet
The Parenteral Drug Association (PDA), a global provider of science, technology and regulatory information and education for pharmaceutical professionals developing and manufacturing sterile drug products, has published a Global Sterile Manufacturing Regulatory Guidance Comparison – With link to Comparison Spreadsheet. The publication compares regulatory guidance documents issued by the US FDA, the EU, the Pharmaceutical Inspection Convention/Scheme and the World Health Organization.
The PDA's Global Sterile Task Force, comprising experts from leading pharmaceutical companies, developed an extensive comparison of each element. The team then conducted detailed 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.'
The document is available at the PDA Bookstore.
It includes a link to the Microsoft Excel spreadsheet, which can be downloaded at no additional cost.