SOP on Procedure for Line Clearance (Manufacturing)

SOP on Procedure for Line Clearance in Manufacturing

1.0 Purpose: This document describes the procedure for Line Clearance in manufacturing area to avoid cross-contamination.

2.0 Scope: This SOP applies for all Product Change Over (s).

3.0 Responsibility: Quality Control Chemist and Production chemist to ensure that procedure is followed.

4.0 Materials and Equipment: As required.

5.0 Procedure:

5.01 Before starting a new batch of a product line clearance must be done to prevent mix-ups / cross contamination.

5.02 Ensure that the entire manufacturing area is cleaned.

5.03 Ensure that all the equipment are cleaned and wash water analysis report is taken, where required.

5.04 Ensure that all equipment bear status label “cleaned” duly signed and dated by Quality Control Chemist.

5.05 Ensure that room temperature / relative humidity, wherever required is within the specified limits.

5.05 Ensure that there is no material lying other than the batch to be manufactured.

5.06 Ensure that there is no document lying other than the batch to be manufactured.

5.07 Ensure that workers are wearing protective uniform.

Appendix 1: Line Clearance Checklist Template

Item	Checked By Operator	Verified by Production Chemist	Approved by QA
Removal of previous batch materials
Equipment cleanliness
Workstation cleanliness
Removal of labels and documents
Floor and wall cleanliness
Batch Production Records

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