Diasorin Ltd

Brief:

GMPG were employed by Diasorin to carry out all IQOQ works for a new aseptic filling suite. 

What we did:

GMPG set a full site qualifiaction team to write, execute and deliver the qualification works for the facility, utility and equipment (FUE). As part of the project, the GMPG site team also developed all engineering SOPS for FUE maintenance operations. The qualification protocols included all ISO 14464 cleanrooms, major equipment, filling machines, autoclaves, WFI and solution preparation support equipment.

Result:

The FUE qualification was delivered on time, to budget, to meet client schedules for production of qualification batches.