Risk Management in a New EMEA Paper

GMP News No. 722

GMP News
9 May 2006
 

Risk Management in a New EMEA Paper

 
Recently, EMEA's PAT Team published a reflection paper describing preliminary recommendations on the representation of PAT-relevant information in applications or variation applications for a marketing authorisation.

One focus of this paper is on the topic of quality risk management.

The paper suggests that each part of a dossier based on the principles of quality risk management should begin with a quality risk management section. The objective of this is that the relevant parts of the dossier can be read together and that they set out the basis for the evaluation/analysis.

Where quality risk management principles are implemented, a summary should include the corresponding method applied. Where this could be helpful, an additional reference to literature on the applied risk management tool should be given.

A table summarising the evaluation/analysis, e.g. on tests of the parameter, effects of deviations, risk levels and possibilities of reducing risks. The document also mentions that the corresponding raw data should be archived so that they can be checked in case of an inspection.

Another table should give an overview of critical points and the way in which they will be handled.

The reflection paper can be downloaded here: http://www.emea.eu.int/Inspections/docs/PATGuidance.pdf

Feedback from the industry on the content of the reflection paper is welcome and should be sent by e-mail to David.Cockburn@emea.eu.int
  

The European Compliance Academy is organising an international training course on ICH Q9. This GMP Education Course can be combined with another one on FDA's new requirements on quality systems:

ICH Q 9 Training Course and FDA's and ICH's New Quality Systems Approach, 31 May – 2 June 2006, Prague, Czech Republic

Risk Assessment with regard to qualification/validation will also be discussed in the course The Validation Manager from May 31 to June 2 in Vienna, Austria.

 
Author:
Sven Pommeranz
On behalf of the European Compliance Academy
 

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