1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that all containers, documents and labels of previous product / batch are removed.
3.3 Ensure that the gloves and accessories of previous product/batch are removed.
3.4 Ensure that the balance verification is done as per the SOP: QAGNxxx
3.5 Check the Temperature and Relative Humidity of the cubicle and enter the same in the Batch Manufacturing Record.
3.6 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.7 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURES:
4.1 Line Clearance Checklist for Raw Material Staging Area, format PRLC:xxx
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