- 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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