CONNECT WITH US

 

 

IPEC-Americas Position Paper on Portable Document Format Specifications

Members of IPEC-Americas recently developed a position paper on “Portable Document Format 
(PDF) Specifications”.
 
The following paper defines the IPEC-Americas position with regards to this matter:
 
Examples of documents sent to pharmaceutical customers in support of their drug applications might 
include:
  • Excipient product certificates of analysis
  • Excipient data sheets and/or brochures
  • Letters of authorization to excipient drug master files
  • Excipient stability information (protocols and data)
  • Copies of excipient test methods and reference standards (e.g. FTIR)
  • Quality System Certificates (e.g. ISO, Responsible Care, etc)
  • MSDS
  • Product Specifications and/or other documentation printed from a global ERP System such as SAP 
 
For your reference, FDA guidance and specifications specific to electronic submissions can be found 
 
IPEC-Americas
ipecamer@ipecamericas.org
571-814-3450
 
Questions? Please contact Kathy Ulman, IPEC-Americas Vice Chair, Science and Regulatory Affairs
(989) 496-6780 or Email