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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 to this SOP.

4.0 ACCOUNTABILITY

Head- Production.

5.0 PROCEDURE

5.1 Line clearance in 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 are 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 batch are taken in manufacturing area.
5.1.11 Line clearance shall be done by Production Officer in manufacturing area, checked & signed by Production Executive and verified & signed by QA.

5.2 Line clearance in 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 machine.
5.2.3 Ensure overprinting metallic stereo of 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 warehouse by making excess material return note, signed by Production Officer and Quality Assurance as defined in the SOP.
5.2.5 Ensure that on line rejected tube send rejected scrap of 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 pipe lines 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 batch are taken in filling area.
5.2.15 Ensure that primary packing materials required for batch are issued by 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 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 machine.
5.3.3 Ensure overprinting metallic / rubber stereo of 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 warehouse by making excess material return note, signed by Production Officer and Quality Assurance as defined in the SOP.
5.3.5 Ensure that on line rejected packing material like - carton, insert send rejected scrap of 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 batch are issued by 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
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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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