Industry Prepares For Emerging ICH Q14 Quality-By-Design Approach To Analytical Methods
Executive Summary
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.
You may also be interested in...
ICH Proposals Would Streamline Analytical Technology Adoption
ICH regulatory members will seek input on guidelines that bring quality-by-design concepts to the development and evolution of the analytical methods required for release of drug products.
Industry Urged To Use ICH Q12 Protocols To Ease Post-Approval Changes For Analytical Methods
Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.
The ICH Plans To Propose Q14 Guideline On Analytical Testing In January
The ICH is expected to release for public comment early next year its draft Q14 guideline establishing a lifecycle approach for analytical testing, as well as a Q2(R2) guideline to add some newer analytical methods.