Jörg Hoffmann

JÃ¶rg Hoffmann is director, CMC Regulatory Compliance at Merck KGaA.

Articles

Analytical Procedure Lifecycle Management: Current Status and Opportunities

Melissa Hanna-Brown;Joachim Ermer;Stephanie Katzenbach;Andy Rignall;Annick Gervais;Jörg Hoffmann;Jette Wypych;Kieran McLaughlin;Phil Borman;Oliver Grosche;Peter Hamilton;Thomas Uhlich;Christof Finkler;Katrin Liebelt

December 2nd 2018

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.

Three Examples of Hypothetical ATPs

Melissa Hanna-Brown;Joachim Ermer;Stephanie Katzenbach;Andy Rignall;Annick Gervais;Jörg Hoffmann;Kieran McLaughlin;Phil Borman;Oliver Grosche;Peter Hamilton;Thomas Uhlich;Christof Finkler;Katrin Liebelt

December 2nd 2018

Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.