1. OBJECTIVE
To lay down the procedure to ensure line clearance before starting the activity in filling area
2. SCOPE
This procedure is applicable to Production, Quality assurance and Quality Control Department
3. RESPONSIBILITY
• Production Incharge
• Manager/Officer QA
4. SAFETY INSTRUCTIONS
• N/A
5. PROCEDURE
5.1 Growing procedure is followed as per SOP.
5.2 Ensure that earlier product run up is completed and no tubes and batch documents lying on or near the machine.
5.3 Ensure overprinting metallic stereo of the earlier batch is removed from crimping assembly and follow the control as per SOP.
5.4 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 SOP.
5.5 Ensure that online rejected tubes send rejected scrap of the tubes after put status label “SCRAP TO BE DESTROYED” and destroyed as per SOP.
5.6 Ensure that status board displayed with mentioning product, Batch No and status with sign and date on filling area.
5.7 Ensure that the tubes filling machine, metering pump and pipelines are cleaned as per SOP
5.8 Ensure that filling area is cleaned as per SOP.
5.9 Ensure that the drain is cleaned as per SOP.
5.10 Ensure that the return air riser filters are cleaned as per SOP.
5.11 Ensure that HVAC system is functional and environmental conditions are met.
5.12 Daily balance performance check and balance calibrated record are updated as per SOP.
5.13 Ensure that the preventive maintenance of machines has been carried out as per schedule.
5.14 Ensure that bulk storage vessels holding the bulk affix “APPROVED” status label by quality control ad batch record required for the batch are taken in filling area.
5.15 Ensure that the primary packing materials required for the batch are issued by warehouse.
5.16 Line clearance shall be done by Production Officer in filling area, Checked and signed by Production Executive and verified and signed by QA.
6. RELATED DOCUMENTS
Format for Line Clearance in Filling Area – Annex. I
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Quality Control Department | 01 | , |
| Production Department | 01 | , |
8. ABBREVIATIONS
Q.A Quality Assurance Department
HVAC Heating ventilation and air conditioning
SOP Standard Operating Procedure
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 10/08/2022 | 00 N/A | First Version |