Sterile parenterals post-approval changes (PAC-SP) group formed at FDA.
STERILE PARENTERALS POST-APPROVAL CHANGES (PAC-SP) GROUP FORMED AT FDA to devise a guidance document for manufacturers of "sterile injectable solutions" making post-approval changes, Office of Generic Drugs Director Douglas Sporn told a Regulatory Affairs Professionals Society meeting July 22. The PAC-SP document should address changes in "packaging components, manufacturing sites, equipment, manufacturing processes and specification and test methods," Sporn said.
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