Saturday, April 4, 2009


1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
Operator, Production Officer.
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Tablet deduster is cleaned as per SOP: PRCL:xxxxx Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx Point No: 3.2, for product change over/expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 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).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.1 Line Clearance Checklist for Tablet deduster, format PRLC:xxxxx

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