SOP on Procedure for Line Clearance in Packaging
1.0 Purpose: This document describes procedure for Line Clearance in Packaging area to avoid mix-ups.
2.0 Scope: This SOP applies to 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.
5.01 Before starting packaging of any new product batch line clearance must be done to prevent mix-ups / cross contamination.
5.02 Ensure that the packaging area is cleaned.
5.03 Ensure that all the equipment to be used in packaging are cleaned.
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 packaging material of previous batch is completely removed.
5.07 Ensure that the shippers of previous batch packed are removed from the packaging line.
5.08 Ensure that there is no document lying other than the batch to be manufactured.
5.09 Ensure that workers are wearing protective uniform.
5.10 Ensure that all the stereos used for coding are removed from the Blister / strip packing machine and returned to production chemist.