Line Clearance - Annexure (Checklist and Lable)

Annexure-I      : Line Clearance Checklist for Manufacturing, Compression / Filling and Coating

             Stage

MANUFACTURING:
Tablet			Capsule
Sr. No.	Checks			Checked By Production (make ‘√’ mark)	Verified By QA (make ‘√’ mark)
1.	Check the House keeping general cleanliness of the area.
2.	Ensure the equipment and utensils are clean, verify it visually.
3.	Ensure the absence of any other materials of the previous products in the area.
4.	Check the temperature & relative humidity of the area.
5.	Check the differential pressure of the area.
6.	Check the functioning and cleaning of return raiser.
7.	Ensure the status label on the equipment.
8.	Check the presence of related Batch Process Record (BPR) issued by QA.
9.	Released status of issued materials.
10.	Check the log card for up dated up to entry of Last activity.
11.	Check the filled line clearance label for the correct product details
Sign & Date :

Compression:                                                                                                              Filling :
Tablet			Capsule
Sr. No.	Checks			Checked By Production (make ‘√’ mark)	Verified By QA (make ‘√’ mark)
1.	Check the House keeping general cleanliness of the area.
2.	Ensure the equipment and utensils are clean, verify it visually.
3.	Ensure the absence of any other materials of the previous products in the area.
4.	Check the temperature & relative humidity of the area.
5.	Check the differential pressure of the area.
6.	Check the functioning and cleaning of return raiser.
7.	Ensure the status label on the equipment.
8.	Check the calibration status of related IPQC equipment.
9.	Check the presence of related Batch Process Record (BPR) issued by QA.
10.	Release Status of product bulk batch.
11.	Check the log card for up dated up to entry of Last activity.
12.	Check the filled line clearance label for the correct product details
Sign & Date :

Tablet Coating :
Sr. No.	Checks	Checked By Production (make ‘√’ mark)	Verified By QA (make ‘√’ mark)
1.	Check the House keeping general cleanliness of the area.
2.	Ensure the equipment and utensils are clean, verify it visually.
3.	Ensure the absence of any other materials of the previous products in the area.
4.	Check the temperature & relative humidity of the area.
5.	Check the differential pressure of the area.
6.	Check the functioning and cleaning of return raiser.
7.	Ensure the status label on the equipment.
8.	Check the presence of related Batch Process Record (BPR) issued by QA.
9.	Released status of the product batch.
10.	Check the log card for up dated up to entry of Last activity.
11.	Check the filled line clearance label for the correct product details.
Sign & Date :

Packing :
Tablet			Capsule
Sr. No.	Checks			Checked By Production (make ‘√’ mark)	Verified By QA (make ‘√’ mark)
1.	Check the House Keeping & general cleanliness of the area.
2.	Ensure the equipment and utensils are clean, verify it  visually
3.	Ensure the absence of any other materials of the previous product in the area.
4.	Check the correctness of the product and packing materials of the product undertaken with respect to the identification and strength.
5.	Check the conveyor belt and surrounding area clean and free from any previous product and it’s any material.
6.	Check the presence of related Batch packing Record (BPR) issued by QA & Released status of issued materials.
7.	Confirm the released status label of the product.
8.	Ensure the status label at the packing line.
9.	Check the filled line clearance label for the correct product details.
10.	Check the log card for up dated up to entry of Last activity.
Sign & Date :

Annexure-II    : Line Clearance Label

COMPANY NAME
MACHINE / AREA / LINE CLEARANCE
Equipment / Area Name	:		ID No.	:
Product Name	:		B. No.	:
Date	:		Stage	:
Previous Product	:		B. No.	:
Done By	:		Date	:
Checked By (Production)	:		Date	:
Checked By (QA)	:	Ref. SOP No.: SOP-QAD-015

Annexure-III   : Line Clearance Checklist for Dispensing

Dispensing Area (Ware-house) :
Sr. No.	Checks	Checked By Production (make ‘√’ mark)	Verified By QA (make ‘√’ mark)
1.	Check the House keeping general cleanliness of the area.
2.	Ensure the equipment and utensils are clean, verify it visually.
3.	Ensure the absence of any other materials of the previous products in the area.
4.	Check the temperature & relative humidity of the area.
5.	Check the differential pressure of the area.
6.	Check the functioning and cleaning of return raiser.
7.	Ensure the status label on the equipment.
Sign & Date :