Procedure for Area line clearance

 In this post Standard Operating Procedure of Procedure for Area line clearance in Pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down the procedure for Procedure for Area line clearance.

2.0 SCOPE:

This procedure is applicable for clearance of line, area and equipments for production department.

3.0 RESPONSIBILITY:

Production: Officer /Executive/Assistant Manager.

Head Production: To ensure execution & compliance.

Head QA: To ensure the compliance.

4.0 PROCEDURE:

4.1 Definition:

4.1.1 Area Clearance is defined as the clearance certification for the area, to be used for the next batch/product, performed by the concerned supervisor and checked by QA supervisor before starting a new batch/product.

Equipment Clearance is defined as the clearance certification for the equipment, 

4.1.2 to be used for the next batch/product, performed by the concerned supervisor and checked by QA supervisor before starting a new batch/product

Start-up Clearance is the checks performed by the concerned supervisor and checked by QA supervisor before starting a new batch/product.

4.1.3 Procedure for Area, Equipment and Start-up clearance: Procedure for area, equipment and start up clearance starts after the concerned operator performs the cleaning activity.

 Area Clearance: The concerned supervisor shall visually ensure the area and then it should be counter 

4.2 checked by QA supervisor:

Cleanliness of area as per SOP of ' Cleaning and sanitization in Production area' SOP.

4.2.1    Ensure proper status label of area as per SOP of 'Status Labeling in Production 

department' SOP.

4.2.1.1   Absence of all items of previous batch/product.

4.2.1.2   Absence of identification tags/labels/documents of previous batch/product.

4.2.1.3   Absence of previous batch/product/its rejects/in process containers.

4.2.1.4  Waste bins should be cleaned properly.

4.2.1.5   Equipment clearance: The concerned supervisor shall visually ensure the equipment and 

then it should be counter checked by QA supervisor:

4.2.1.6   Cleanliness of equipment as per respective equipment SOP.

4.2.2    Ensure proper status label of equipment as per SOP of 'Identification and Status Labeling 

Procedure' SOP.

4.2.2.1   Absence of previous batch/product/its rejects/in process containers.

4.2.2.2   Ensure the updating of cleaning time in sequential log/line clearance record for 

equipment.

4.2.2.3   Filling of sequential log and BMR/BPR for area/line clearance.

4.2.2.4   Start up clearance: Start up clearance should perform after completion of area and 

equipment clearance, before starting the operation of new batch/product. The concerned

4.2.2.5  supervisor shall ensure the following:

4.2.3   Ensure that area and equipment clearance has been performed.

4.2.3.1   Ensure proper environmental condition as per BMR/BPR.

4.2.3.2   Ensure that the Balance/Check-weigher is calibrated /daily performance checks done.

4.2.3.3   Ensure that the equipment is assembled with proper change parts and ensure the proper 

fittings of all accessories.

4.2.3.4   Ensure the BMR/BPR is available with the products.

Ensure the proper status of the product and container to be taken for next steps.

4.2.3.5   Check all the above-mentioned points before starting the manufacturing process in

4.2.3.6   the area/machine, Before starting the process, take area and equipment clearance from QA 

supervisor get signed in the Cleaned label and/or Line Clearance Record and/or BMR/BPR.

4.2.3.7 If QA supervisor is not available, then clearance can be given by any other production Executive.

4.2.3.8 Responsibility for Production:

4.3 To maintain the area cleanliness as per defined procedure.

4.3.1 To maintain the equipment clearance/cleanliness as per defined procedure.

4.3.2 To make entry in BMR/BPR for area & equipment clearance.

4.3.3 To maintain the activity in equipment Sequential log/Line Clearance Record.

4.4 Responsibility for Quality Assurance:

4.4.1 To check the area cleanliness as per defined procedure.

4.4.2 To check the equipment clearance as per defined procedure.

4.4.2 To check entry in BMR/BPR for area & equipment clearance.

4.4.2 To check proper filling of area and equipment sequential log.

5.0 ANNEXURE (S) :

ANNEXURE –I: Equipment Sequential log.

6.0 REFERENCE (S):

In-House

7.0 ABBREVIATION (S) / DEFINITION (S):

BMR: Batch manufacturing record.

BPR: Batch Packing Record.

QA: Quality Assurance.

Prod.: Production