Since the 2017 publication “Qualification 4.0 – Unused Potential” was so well received, Ralf Gengenbach has once again dedicated himself to this topic. Part 1 “Basic Principles” of a 4-part publication series “Basic Principles of Effective and Efficient Qualification” was published in pharmind 01/2020.
The publication series further examines the known problems of qualification in the pharmaceuticals industry and offers proposed solutions for especially critical points. Now the focus is on “HOW”.
Part 1 covers the fundamentals, the correct understanding of key concepts, the alpha and omega of effective and efficient implementation. What are the differences between qualification and technical inspections, and what exactly is a user requirement specification (URS)? The author answers these and more questions in detail.
The publication is available for download (German language) under www.gempex.com/GMP Knowledge.
This publication series is to be concluded in 2020. Part 2 deals with planning, part 3 with implementation and part 4 is about comparison with the regulations.
You may contact the author directly at: Ralf.Gengenbachgempex.com