1. OBJECTIVE
To lay down the procedure to ensure line clearance before starting the activity in manufacturing 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 Gowning procedure is followed as per SOP.
5.2 Ensure that status board displayed with mentioning product, Batch No and status with sign and date on manufacturing area.
5.3 CLEANED status label is fixed in the all vessels and pump as per SOP.
5.4 Ensure that manufacturing area is cleaned as per SOP.
5.5 Ensure that drain is cleaned as per SOP.
5.6 Ensure that the return air riser filters are cleaned as per SOP.
5.7 Ensure that the HVAC system is functional and environmental conditions are met.
5.8 Daily balance performance check and balance calibration record are updated as per SOP.
5.9 Ensure that the preventive maintenance of machines has been carried out as per schedule.
5.10 Ensure that raw material and batch record required for the batch are taken in manufacturing area.
5.11 Line clearance shall be done by production officer in the manufacturing area, checked and signed by Production Executive and verified and signed by QA.
6. RELATED DOCUMENTS
Format for Line Clearance in Manufacturing 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 |