| STANDARD OPERATING PROCEDURE | ||
| Title | : | Procedure For line clearance activities during processing of product |
OBJECTIVE
To lay down the procedure for Line Clearance.
SCOPE
This procedure is applicable for line clearance activities during processing of product.
RESPONSIBILITY
Officer-Production
Officer-IPQA/QA
ACCOUNTABILITY
Manager-Production
Manager-Quality Assurance
PROCEDURE
Officer-Production should place the line clearance status board after ensuring the cleanliness and absence of foreign matters in area and request to Officer-QA.
On receipt of request from production for line clearance, Officer-QA should take the line clearance checklist as given in BMR/ BPR.
Officer-QA should check/ verify each and every activity as per format related to particular operation. Record the observation in the sheet and if found satisfactory, clear the line for next processing after putting his/ her signature in respective status board.
In case any deficiency related to any of the activity is found, he/ she should not clear the line for next processing and inform the Officer/ Manager-Production for remedial action.
Officer/ Manager-Production should rectify the deficiency and request again Officer for inspection.
Officer-QA should re-inspect the area/ machine, etc. for the deficiency noticed originally, if found okay, clear the line for processing.
If the deficiency is not yet rectified, he should not clear the line and ensure that next processing will not start without QA line clearance. Repeat the same as mentioned in above till deficiency is rectified.
General Procedure
Check general cleanliness of the area and equipments as per the attached format.
Ensure that previous batch is removed from the area and no excess Packaging/ Raw material is available in the area.
Check temperature, RH and differential pressure of the area if applicable.
Ensure availability of BMR/ BPR of the product to be manufactured/ Packed.
Dispensing
Check general cleanliness of the area and equipments as per the attached format.
Ensure availability of BMR of the product to be dispensed.
Check temperature, RH and differential pressure of the area and initial in sheet.
Ensure that the weight and weighing balance are calibrated.
Ensure that the Bulk is released from QC.
Ensure the ON / OFF position of LAF.
Put signature on line clearance status board.
Manufacturing
Check general cleanliness of the area and equipment as per the attached format.
Ensure availability of BMR of the product.
Ensure that the area is free from previous product.
Check temperature, RH and differential pressure of the area and initial in sheet.
Give the line clearance for the product to be packed by putting signature on the line clearance sheet in the BPR.
Filling
Check general cleanliness of the area and equipment as per the attached format.
Ensure availability of BMR of the product.
Ensure that the area is free from previous product.
Check temperature, RH and differential pressure of the area and initial in sheet.
Give the line clearance for the product to be packed by putting signature on the line clearance sheet in the BPR.
Polishing
Check general cleanliness of the area and equipments as per the attached format.
Ensure availability of BMR of the product.
Ensure that the area is free from previous product.
Visual Inspection
Check general cleanliness of the area and equipments as per the attached format.
Ensure that no other product is lying on the inspection bench except the product to be inspected.
Put signature on line clearance status board.
Blistering
Check general cleanliness of the area and equipments as per the attached format.
Ensure availability of BMR/BPR of the product.
Check all aluminum foils, PVC/PVDC foils, stereos of previous batch is removed from the area and no excess packaging material is available in the area.
Check temperature, RH and differential pressure of the area and initial in sheet.
Packing
Check general cleanliness of the area and equipments as per the attached format.
Ensure availability of BPR of the product to be packed.
Ensure that the labels, cartons, stereos, leaflets and finished product of previous product are not lying on the line.
Identify the product and check all packaging materials as per packaging material requisition slip.
Ensure the conveyor belt is clean.
Give the line clearance for the product to be packed by putting signature on the line clearance sheet in the BPR.
ABBREVIATIONS
SOP – Standard Operating Procedure
QA – Quality Assurance
FORMAT
N/A
DISTRIBUTION LIST
| Sr. No. | Copy No. | Department |
| Quality Assurance |
