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
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