sop for Line Clearance

1.0 OBJECTIVE :
1.1 To lay down the Procedure for Line Clearance.

2.0. SCOPE :
2.1 This procedure is applicable for Line Clearance of Production and warehouse dispensing Area by Quality Assurance personnel at ABC Pharma Pvt Ltd.

3.0 RESPONSIBILITY :
3.1 Executive/Supervisor of In Process Quality Assurance

4.0 ACCOUNTABILITY :
4.1 Manager- Quality Assurance Department.

5.0. PROCEDURE :

5.1 Production department shall take line clearance from QA in the following condition:
5.1.1 Product to product change over.
5.1.2 Batch to batch change over.
5.1.3 Change of primary packing material, printed packing material and pack style.
5.1.4 After machine breakdown followed maintenance work.
5.1.5 If same batch is operated on more than one equipment/machine at a same time, take line clearance for all equipment/machine involved in production/packing.
5.1.6 If packing of same batch is continued on next day (primary/secondary packing).
5.2 Respective department shall ensure that all points of checklist as per BMR/BPR are fulfilled and record the same in BMR/BPR. If everything is complying, Officer/Executive/designee shall call QA Officer/Executive/designee for line clearance of area/line for the process.

5.3 Officer/Executive/ Designee QA shall ensure that all points of respective checklist of BMR/BPR are fulfilled and production person has filled the checklist of BMR/BPR appropriately. Officer/Executive/Designee QA shall record the same in respective checklists. If everything is complying, Officer/Executive/Designee QA shall give clearance of that area/ equipment for the process.
5.4 The QA Officer/Executive/Designee shall also record the line clearance given in BMR / BPR.
5.5 If any abnormal finding is observed by officer/executive/Designee QA, he shall raise the non-conformance report and proceed as per SOP.
6.0. ABBREVIATION:

Sr. No.	Abbreviation used	Full form of abbreviation used
1.0	SOP	Standard Operating Procedure
2.0	QA	Quality Assurance department
3.0	WH	Ware house
4.0	BMR	Batch Manufacturing record
5.0	BPR	Batch Packing record

7.0 ATTACHMENTS (ANNEXES) : Nil

8.0. REFERENCE:

Sr. No.	Reference Title
1.0	Schedule M (Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products)

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