Recommissioning of equipment

Quality Assurance
1

Dear All,

Could you please provide the procedures for recommissioning of a decommissioned equipment, what are the qualification and quality requirements?
Thanks

2

For recommissioning of equipment, following aspects should be complied,

  • Change control proposal with Risk assessment
  • QA Approval on Change proposal
  • Conduct IQ, OQ of Equipment
  • Ensure calibration of measuring devices affixed on it
  • Write operation, cleaning and maintenance SOPs of that equipment.
  • Conduct the PQ
  • Approval by QA for IQ, OQ, PQ
  • Development usage log book of that equipment
    Upon release of the equipment by QA, make necessary changes in the Batch Manufacturing or Packing records (Master)
  • Evaluate Regulatory impact
  • Start using the equipment for routine production or packing of the products as applicable.
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3

Thank you Mr. Sunil,
could you just explain the things to be covered in Risk assessment.

Thanks

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4

Risk assessment will depend upon the type of products to be handled in that equipment and your SOP on Risk management / assessment.

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