EMA publishes New Process Validation Guideline

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New Drug Approvals

EMA publishes New Process Validation Guideline

After the publication of the Annex 15 draft at the beginning of February 2014, the EMA made a move towards the revision of its process validation guideline. The final document was published on 27 February 2014. For a long time now, the EMA had already announced this revision in a concept paper. What’s new?  click here

After the publication of the Annex 15 draft at the beginning of February 2014, the EMA made a move towards the revision of its process validation guideline. The final document was published on 27 February 2014. For a long time now, the EMA had already announced this revision in a concept paper. The objective of the revision was to integrate modern GMP aspects:

  • Integration of the ICH Q8, Q9 and Q10 Guidelines
  • Incorporation of Process Analytical Technology (PAT), Quality by Design (QbD) and Real-Time Release Testing…

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