How much GMP must be reflected in the Dossier?

The European Medicines Agency EMA has published a "Concept Paper on the need for revision of the note for guidance on manufacture of the finished dosage form (EMA/CHMP/QWP/324350/2013)".

The objective of the guideline is to underline all aspects of manufacture that are important for both applicant and regulator. The guideline also indicates that information which fall under Good Manufacturing Practice (GMP) should not be part of the MA file and that only product specific issues need to be described. However, new aspects should be described in the new guideline, like for example:

  • holding time conditions of bulk product
  • process validation and real time release testing
  • ICH guideline Q8 on Pharmaceutical Development, Q9 on Risk Management and Q10 on Quality Systems
  • shipping transportation conditions

and it should then follow CTD structure.

The Quality Working Party now recommends the revision of the Note for Guidance on manufacture of the finished dosage and to update information about manufacture of finished dosage form in line with recent development and the current EU legislation. It is anticipated that the draft guideline could be available 6 months after adoption of the concept paper and that this would then be released for external consultation for 6 months before its finalisation within another 6 months.

Once the proposed guideline is finalised, it will replace the "Note for Guidance on Manufacture of the Finished Dosage Form" (CPMP/QWP/486/95). End of consultation and deadline for comments is 31 December 2013.

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