RE: RE: mediafill
Contribution from Kodancha written on 4/27/2012 at 05:49
Original contribution: RE: mediafill written by JD Mallet on 4/21/2012 at 05:12)
Dear Sanjeev & Mallet,
As per the EU-GMP Annex-1, process simulation trials to be repeated in case of significant change in the HVAC-System.
But the periodic replacement of the HEPA filter is like to like change. Will it need any process simulation trials to be repeated?
Answering this Contribution: