How can qualify the PLC and MMI Qualification/Validation?

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
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Dear All,

I am going to qualify the Rapid Mixer Granulator and Fluid BEd Processor. These equipments are operated through PLC system. Now my quaestions are on the PLC qualifications.

  1. What are the requierments to be taken for qualification of PLC.
  2. What are the checks to be performed during the IQ.
  3. What are the checks to be performed during the OQ.
  4. What are the factors to be considered for PLC designing.

Kindly supply the your valuable answers at earliest.

Thanks

Pulla Reddy Karnati.

2

Pulla
Get a copy of GAMP 5, GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems , Both can be found at