ICH Q10 Emphasises Quality Management Systems

GMP News
6 June 2007

ICH Q10 Emphasises Quality Management Systems

As reported in our GMP Newsletter from 31 May 2007 the new guideline concentrates on a continuous improvement process and also emphasises further elements supporting the life cycle approach:

  • CAPA
  • Change Management
  • Technology Transfer (seen as basis for process control, process validation and a continuous improvement process)

For instance, the document indicates that a pharmaceutical company should have established a system to take corrective and preventive measures (CAPA). These can possibly follow from complaints, deviations, recalls or observations at audits, inspections or from monitoring results. The analyses within the system should aim at identifying the real cause. The result should be a better process and product understanding, from which improvements are derived.

A continuous improvement can, of course, lead to changes. For that reason an efficient Change Control/Change Management System is required. It is important to differentiate between changes before and after authorisation though, when regulatory requirements determine the procedure. Proposed and possibly necessary changes should be evaluated in a risk analysis to estimate potential regulatory consequences. Ultimately all changes have to be recorded and evaluated – before as well as after the change.

The changes that were part of the process development, deliver documented information and the necessary process understanding to partly transfer complex process successfully; irrespective if it is a transfer from the galenics development to production or a transfer of an already validated product to another site.

Discuss the new ICH Q10 guideline with a representative from the ICH Q10 Expert Working Group

At the 2nd European GMP Conference in Heidelberg, Germany, on 25/26 June 2007, ICH Q10 Expert Working Group Member Dr. Jacques Morénas from the French authority AFSSAPS will introduce the new ICH Q10 document. More than 20 speakers from international authorities as EMEA and FDA and from the industry will provide information on the latest developments.

Also, further information on quality management systems will be presented in the ECA education course GMP and FDA compliant Quality and Documentation Systems in Copenhagen on 22/23 October 2007.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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