Consequences of the new ICH Guideline Q 10 (Pharmaceutical Quality Systems)

On 4 June 2008, the ICH Guideline "Pharmaceutical Quality Systems" was passed as step-4 document and thus now exists in a form in which this document can be brought into force in Europe, the USA and Japan. See also our news from 2 July 2008

The document describes a model for an effective quality management system for the pharmaceutical industry. It is based on the quality concepts of ISO, contains GMP and complements the two ICH Guidelines Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management). ICH Q 10 does not intend to define new requirements rising above the former regulatory requirements. Accordingly, the contents of ICH Q10 that go beyond regional GMP requirements are optional.

Topics dealt with in this document include among others knowledge management and quality risk management.

ICH Q10 defines knowledge management as a "systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components".

Quality Risk Management is defined as follows: A systematic "approach to identifying, scientifically evaluating and controlling potential risks 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:

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

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

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