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Recommended IMD-A Implementation Steps For EU Customers

STEP 1

Initiate early phases of validation preparation

STEP 2

Contact local GMP inspector and inform him/her of IMD-A  evaluation and implementation plans

STEP 3

Conduct DQ, IQ, OQ, PQ

STEP 4

Have Quality Expert Report written and implement IMD-A system using internal Change Control (as long as specs. and EM method are not called out in MA)

STEP 5

Contact local EMA inspector and QP for review of system validation material (BioVigilant to make EP 5.1.6 test data available for review)