Pharmaceutical Industry Adopting QbD for Analytical Testing
This article was originally published in The Gold Sheet
Executive Summary
Both the pharmaceutical industry and regulators are exploring new QbD approaches for analytical method development. FDA regulators have approved analytical QbD submissions and say that regulatory relief will be granted to those firms that use this approach, while the EU has been less accepting.
You may also be interested in...
Industry Prepares For Emerging ICH Q14 Quality-By-Design Approach To Analytical Methods
EU industry group advises drug makers on how to prepare for enhanced quality-by-design approaches to analytical methods that the International Conference on Harmonization plans to propose early next year. ICH recently shared its concept, which involves revising its Q2(R2) guideline and adding a Q14 guideline, and its business plan for establishing the guidance.
Firms That Get Complete Response Letters Might Get Inspected By US FDA Six Months After Replies
While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.
COVID-19 Spurs WHO To Revise Guidance On Technology Transfers
The WHO proposes to revise 2011 guidance on technology transfers to ease the hand-off of COVID-19 drugs and vaccines from research and development facilities to commercial sites.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: