Lachman Consultants Blog Integrating QRM, Data Integrity, and Annex 1

On October 26, 2020, a business plan was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that eventually resulted in a holistic revision to ICH Q9, "Quality Risk Management," the "R1" of the framework. The four areas of concern were identified as: High levels of subjectivity in risk assessments [...]The post Integrating QRM, Data Integrity, and Annex 1 appeared first on Lachman Consultant Services, Inc..