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IMD-A Implementation Steps in EU

Implementation Steps for EU Customers:

STEP 1

Initiate early phases of validation preparation

  • Write up description of technique, including application principle
  • Perform Risk Benefit Analysis
  • Work with internal statisticians to develop test plan (# of samples, acceptance criteria, etc.)
  • Include Qualified Person in review of IMD-A strategy
  • Conduct prefeasibility and/or feasibility testing

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)