Procedure for line clearance of equipment & area

1.0	PURPOSE To describe the procedure for line clearance of equipment & area at various stage of manufacturing of different dosage form.
2.0	SCOPE The scope of this document is to clarify the role of Q.A for line clearance during the various activities.
3.0	RESPONSIBILITY IPQA Chemist
4.0	ACCOUNTABILITY  Head Quality Assurance
5.0	PROCEDURE
5.1.1 5.1.2 5.1.3 5.1.4 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 5.2.8 5.2.9 5.2.10 5.2.11 5.2.12 5.2.13	Line clearance should be carried out during batch to batch change over by production chemist. Line clearance should be carried out during product to product change over by two Production chemist and Q.A. chemist. Line clearance for all critical equipment and production area should be given on the basis of individual equipment. The checklist should include checking of all machine places where product packing material may get trapped. CRITERIA FOR LINE CLEARANCE: Ensure that the area/ machine are cleaned as per the cleaning SOP. Check visually for the cleanliness of area and ensure for no remnants of the previous product/batch is present.. Check “cleaned” status label of area and ensure the name of previous product and batch no. is recorded. Verify the equipment usage and cleaning log of respective equipment and cleaning operation of area are updated up to the stage.   Visually inspect the equipments and area for cleanliness and no remnants of previous product /batch present. Equipment to be cleared for process should be completely dry and bear “Cleaned” status label. Ensure that the accessories of previous product are cleaned and Accessories box of the same are cleaned as per SOP. Verify for the calibration status and record of weighing balance. Verify the wash water /swab sample is released by Quality control Deptt.. Ensure the functioning of AHU (Air Handling Unit) and the pressure differential of the process area exhibited by magnahelic gauge. Ensure that the temperature and relative humidity of the compression area must be under specified limit and these values are recorded in Batch Processing Record. After compliance of above checks & verifying all the details filled in Batch Processing Record give the line clearance by verifying the checklist. Sign in the space provided for line clearance in Batch processing record  after giving line clearance for each activity.
6.0	REFERENCES     NIL

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Nil

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Deptt.
Controlled office Copy No. 2							Head Production (Tablet) Deptt.
Controlled office Copy No. 3							Head Production (Liquid) Deptt
Controlled office Copy No. 4							Head Production (External) Deptt
Controlled office Copy No. 5							Head Production (Soap) Deptt
Controlled office Copy No. 6							Head Warehouse (External) Deptt
Controlled office Copy No. 7							Head Warehouse (Main) Deptt
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)