On 4 June 2008, the ICH Guideline "Pharmaceutical Quality Systems" was passed as step-4 document anisks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle".

The use of knowledge management and quality risk management will enable a firm to implement ICH Q10 effectively and successfully. In this way, the three main targets of ICH Q10 can be achieved:
1. To realise and provide products meeting the needs of patients, health care professionals, authorities and other internal or external customers.
2. To develop and effectively monitor control systems for process performance and product quality.
3. To facilitate continual improvement (improving the product quality, optimising the processes, reducing variability of the processes, developing innovations, etc.).

With regard to knowledge management, ICH Q10 also says that knowledge about a product and about a process must be managed starting with the development via the commercial phase to the end of the product. Development activities should e. g. include scientific approaches in order to gain the corresponding knowledge about the product as well as process understanding.

The knowledge sources include:

• existing knowledge (documented publicly or internally)
• pharmaceutical development studies
• technology transfer activities
• innovation
• continual improvement
• and change management.

Other focus topics of the ICH Q10 Guideline are:

• management responsibilities
• continual improvements of processes and product quality and
• the continual improvement of the pharmaceutical quality system

The complete document can be found here:

http://www.ich.org/LOB/media/MEDIA3917.pdf

Knowledge Management and Risk Management are important topics that will be presented at the University of Heidelberg PAT Conference 2008.

Author:
Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)