1.0 SCOPE:
To provide the guidelines for the effective line clearance of the Capsule inspection machine.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP for General cleaning
3.2 Ensure that the Capsule inspection belt is cleaned as per the relevant SOP: xxxxx Point No 3.1, for Batch change over/at the end of shift or as per the SOP: xxxxxx; 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 services 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 Ensure that the balance is verified as per the SOP: QAGN:xxx.
3.7 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 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).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxxxx.
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Capsule inspection belt, format PRLC:xxxxx.
