SOP on Precautions during on line maintenance of machine and re-start operation.

  • SOP on Precautions during on line maintenance of machine and re-start operation.
  • Objective:To lay down a procedure for precautions during on line maintenance of machine and checks to start its operation.
  • Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical company.
  • Responsibility
    • Production Supervisor / Officer / Executive shall be responsible for implementation of this procedure.
    • Head-Production / designee shall be responsible for compliance of the procedure as per this SOP.
  • Accountability:
    • Head-Production and head QA shall be accountable for compliance of the procedure as per this SOP.
  • Abbreviations and Definitions:
  • Type-A -Product to Product cleaning procedure
  • Type-B – Batch to Batch cleaning procedure
  • Procedure
    • Switch ‘OFF’ the machine when online maintenance shall be required.
    • Prepare the maintenance memo with detailed nature of breakdown and forward it to the engineering department.
    • Cover the online product or material collecting containers with the lid and keep them aside on a pallet.
    • Allow the engineering person to perform the maintenance work. After the completion of the maintenance work ensure that the maintenance is done properly.
    • Clean the machine with cleaning procedure Type-A if contact parts included in the maintenance or otherwise clean the machine with cleaning procedure Type-B.
    • If the maintenance work of machine / equipment continues for more than 24 hours remove the material / product from respective machine and transfer the material in containers duly labeled as per current version of SOP. to the quarantine.
    • Clean the whole machine / equipment with cleaning procedure Type-A.
    • After completion of cleaning switch ‘ON’ the machine.
    • Run the machine in empty condition to check for the satisfactory maintenance work.
    • In case of time specified for manufacturing / packing operation, after the maintenance work of the relevant equipment gets completed, carry out the manufacturing operation for remaining period of time left out for completion of operation.
    • Record the details of machine / equipment breakdown in relevant machine logbook..
    • If printers attached to the PLC based equipment or weighing balance are under maintenance then record the data of the process manually in the space provided in respective BMR.
    • In case of compression / filling operation, collect the tablets of first 2 to 3 rotations as rejected residues with proper label on their polybags.
    • In case of compression / filling operation, take the new sample after the machine trial and again check the in process parameters of tablets / capsules and record in the BMR of respective product. 
  • Forms and Records:
  • Nil
  • Distribution
    • Master Copy –  Documentation Cell (QA)
    • Controlled Copies ­–  Production, Quality Assurance
  • History
Date Revision

Number

Reason for revision
       – 00 New SOP

 

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