FDA Moving Toward PAT Standardized Nomenclature And Definitions
This article was originally published in The Pink Sheet Daily
Executive Summary
The process analytical technology component of FDA's drug quality initiative will be assisted by an independent standards-making effort and agency encouragement of comparability protocols. Part 11 and dispute resolution are other quality initiative components drawing industry input.
You may also be interested in...
FDA Expects 25 Formal Dispute Resolution Requests Annually On GMP Issues
The agency has not changed its projection that the number of annual requests for formal dispute resolution will reach 25, almost double the current number of informal disputes, despite the results of a year-long pilot program that had little industry participation.
FDA Expects 25 Formal Dispute Resolution Requests Annually On GMP Issues
The agency has not changed its projection that the number of annual requests for formal dispute resolution will reach 25, almost double the current number of informal disputes, despite the results of a year-long pilot program that had little industry participation.
Rapid Microbiology Methods Submissions Reviewed By Special FDA Team
The agency’s four-person rapid microbiology methods review and inspection team was formed under the process analytical technology initiative. FDA is “very enthusiastic” about methods that allow for faster microbial testing.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: