Equipment change in facility

GMP
1

what is the procedure of change any equipment from facility and introduce the new equipment in same place ???

2

Prepare exclusion form and exclude machine from BMR and add in exclusion list.
For new machine
Prepare qualification documents
include in new machine list and add in BMR

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3
  1. Initiate decommissioning report for old machine.
    2.Conduct room/area qualification.
    3.Perform installation of new equipment.
    4.PQ can be done in production batches if not critical operation of equipment.
    5.Prepare equipment handover certificate to production.

Thanks

4 Likes
4

first raise a CCF

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6

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