Concept Paper: Quality Management Challenges in Pharmaceutical Industry

The pharmaceutical industry is struggling with the implementation of the ICH Q10. The benefits of the ICH Q10 are recognized but coherence with Good Practice regulations is not that clear. The challenge is to adapt from a regulatory driven reactive organization into a process based learning organization that proactively anticipates business and compliance challenges and enables the development and manufacture of good quality medicinal products and medical devices.

The set up of a process oriented Pharmaceutical Quality Assurance Management System (QAMS) was presented by Henny Koch* at the 2010 ECA Masterclass on Pharma Quality Excellence. The presentations were part of a thesis investigation which has been made available to the ECA for general publication. You will find it in the ECA Members' Area under Documentation from Conferences and Education Courses.

A QAMS following the ICH Q10 principles requires detailed process identification to cover dynamics and expectations of customers and business. Process understanding is created following the concepts of Total Quality Management.

The Deming Cycle is adapted to differentiate improvement actions. The process approach to identify, organize and manage the product lifecycle processes followed the ICH Q10 chapters for Responsibilities, Resources, Product Realization and Performance & Improvement. Strong reference and correlation has been obtained by ordering pharmaceutical processes from a strategic, tactical and operational business perspective and resulted in insight for a stringent CAPA system.

The obtained pharmaceutical QAMS creates the required reference and is in compliance with international developments and governmental expectations as expressed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and described in the ICH Q10 guideline.

Henny Koch
Global Compliance Organization of Merck

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