Follow
1. Ensure that product containers, materials, status labels, BMR of previous process operation and relevant documents are removed.
2. Ensure that area along with respective equipments is cleaned as per the cleaning procedure and records are updated and within validity period as per production SOP.
3. Ensure that temperature, relative humidity and differential pressure of the area is suitable for compression/encapsulation.
4. Ensure that balance is calibrated; bubble point is in the centre position. Ensure that all equipments bears ‘Qualified’ status label.
5. Ensure that appropriate IBC with granules are brought for compression or encapsulation and are approved by QA. Ensure that cleaned bins/containers are using during operation.
6. Ensure that software setting parameter entered in Programmable Logical Control (PLC) for the previous batch is closed and is clear for the current batch setting.
7. Ensure that approved SOPs and work instructions are being followed.
8. Ensure that BMR is updated till the current stage.
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