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

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