Discussion Forum

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?


With Regards,

Kodancha

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