SOP for Line Clearance in Manufacturing Area : Pharmaceutical Guidelines

SOP for Line Clearance in Manufacturing Area

Standard operating procedure to ensure line clearance before starting the activity in manufacturing, filling and packing area.

1.0 PURPOSE

To lay down the procedure to ensure line clearance before starting the activity in manufacturing, filling and packing area.

2.0 SCOPE

The procedure is applicable to line clearance before starting the activity in manufacturing, filling and packing area.

3.0 RESPONSIBILITY

Junior Officer/ Technician - Implementation of this SOP.
Production Officer - Execution of this SOP.
Production Executive - Compliance with this SOP.

4.0 ACCOUNTABILITY

Head- Production.

5.0 PROCEDURE

5.1 Line clearance in the manufacturing area

5.1.1 Gowning procedure is followed as per SOP.
5.1.2 Ensure that status board displayed with mentioning Product, Batch No and Status with Sign & Date on manufacturing area.
5.1.3 Ensure that the ointment manufacturing plant, bump pump & bulk storage vessel is cleaned as per SOP and ‘CLEANED’ status label is fixed in the all vessels and pump as per SOP.
5.1.4 Ensure that the manufacturing area is cleaned as per SOP.
5.1.5 Ensure that the drain is cleaned as per SOP.
5.1.6 Ensure that the return air riser filters are cleaned as per SOP.
5.1.7 Ensure that HVAC system is functional and environmental conditions are met.
5.1.8 Daily Balance Performance checks and Balance Calibration records are updated as per SOP.
5.1.9 Ensure that preventive maintenance of machines has been carried out as per the schedule.
5.1.10 Ensure that Raw materials and batch records required for the batch are taken in the manufacturing area.
5.1.11 Line clearance shall be done by Production Officer in the manufacturing area, checked & signed by Production Executive and verified & signed by QA.

5.2 Line clearance in the filling area

5.2.1 Gowning procedure is followed as per SOP.
5.2.2 Ensure that earlier product run up is completed and no tubes and batch documents are lying on or near the machine.
5.2.3 Ensure overprinting metallic stereo of the earlier batch is removed from crimping assembly and follow the control as per SOP.
5.2.4 Ensure that primary packing material like - empty tubes remaining after batch completion are returned to the warehouse by making excess material return note, signed by Production Officer and Quality Assurance as defined in the SOP.
5.2.5 Ensure that online rejected tube send rejected scrap of the tube after put status label “SCRAP TO BE DESTROYED” and destroy as per the SOP.
5.2.6 Ensure that status board displayed with mentioning Product, Batch No and Status with Sign & Date on filling area.
5.2.7 Ensure that the tube filling machine, metering pump and pipelines are cleaned as per SOP and ‘CLEANED’ status label is fixed as per SOP.
5.2.8 Ensure that the Filling area is cleaned as per SOP.
5.2.9 Ensure that the drain is cleaned as per SOP.
5.2.10 Ensure that the return air riser filters are cleaned as per SOP.
5.2.11 Ensure that HVAC system is functional and environmental conditions are met.
5.2.12 Daily Balance Performance checks and Balance Calibration records are updated as per SOP.
5.2.13 Ensure that preventive maintenance of machines has been carried out as per the schedule.
5.2.14 Ensure that bulk storage vessel holding the bulk ointment/ cream and affix “APPROVED” status label by Quality Control and batch records required for the batch are taken in filling area.
5.2.15 Ensure that primary packing materials required for the batch are issued by the warehouse.
5.2.16 Ensure that batch crimping metallic stereos of new batch are fixed to crimping stations. Take out specimen on empty tubes duly checked and signed by Production Officer and Q.A. Officer. Retain this specimen to BPR.
5.2.17 Line clearance shall be done by Production Officer in filling area, checked & signed by Production Executive and verified & signed by QA.

5.3 Line clearance in the packing area

5.3.1 Gowning procedure is followed as per SOP.
5.3.2 Ensure that earlier product run up is completed and no tubes, carton, insert and batch documents are lying on or near the machine.
5.3.3 Ensure overprinting metallic / rubber stereo of the earlier batch is removed from crimping assembly and follow the control as per SOP.
5.3.4 Ensure that secondary packing material like - carton, insert remaining after batch completion, are returned to the warehouse by making excess material return note, signed by Production Officer and Quality Assurance as defined in the SOP.
5.3.5 Ensure that online rejected packing material like - carton, insert send rejected scrap of the carton after put status label “SCRAP TO BE DESTROYED” and destroy as per the SOP.
5.3.6 Ensure that status board displayed with mentioning Product, Batch No and Status with Sign & Date on packing area.
5.3.7 Ensure that the cartonator machine is cleaned as per SOP and ‘CLEANED’ status label is fixed as per SOP.
5.3.8 Ensure that the Packing area is cleaned as per SOP.
5.3.9 Ensure that the return air riser filters are cleaned as per SOP.
5.3.10 Ensure that HVAC system is functional and environmental conditions are met as per SOP.
5.3.11 Daily Balance Performance checks and Balance Calibration records are updated as per SOP.
5.3.12 Ensure that preventive maintenance of machines has been carried out as per the schedule.
5.3.13 Ensure that secondary packing materials required for the batch are issued by the warehouse.
5.3.14 Ensure that batch crimping metallic/ rubber stereos of new batch are fixed to crimping stations. Take out specimen on empty carton duly checked and signed by Production Officer and Q.A. Officer. Retain this specimen to BPR.
5.3.15 Line clearance shall be done by Production Officer in packing area, checked & signed by Production Executive and verified & signed by QA.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The Department
6.4 HVAC: Heating Ventilation and Air Conditioning

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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4 comments: Post Yours! Read Comment Policy ▼

  1. Why line clearance is necessary before starting a batch?

    ReplyDelete
    Replies
    1. Line clearance ensures that area is cleaned and ready for the next batch.

      Delete
  2. Dear sir pls explain about Which guidelines are followed to perform in process checks during compression

    ReplyDelete
  3. There is no any regulatory (Schedule M) requirement for QA verification. Sir if you have any guideline which mentions QA verification is must then please let me know.

    ReplyDelete


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