Recommissioning of equipment

Dear All,

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

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.
1 Like

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

Thanks

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