SOP for Tablet Branding Machine

1.0 OBJECTIVE

To lay down the Procedure for Operation of Tablet Branding Machine.

2.0 SCOPE

This SOP shall be applicable for Tablet Branding Machine in Production Area.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 PROCEDURE

5.1 Production person shall ensure the cleanliness of the Tablet Branding Machine & area and ‘CLEANED’ label on it.
5.2 Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, Batch Details to equipment & area as per BMR.
5.3 Branding details to be given to the operator by production pharmacist.
5.4 Set the machine with appropriate disk and master die roller.
5.5 Use only food grade quality ink.
5.6 Take the drums of tablets serially for branding; Ensure that the Q.C. has given the ‘Released For Branding’ status for the batch.
5.7 Switch “ON” the mains.
5.8 Discard tablets of first two to three rotations in water.
5.9 Check the branding quality of further rotation and get the branding approved by the pharmacist, Officer and QA person.
5.10 Collect the branded tablets in Labeled containers with double polybags inside and duly labeled.
5.11 At the process end switch “OFF” the mains.
5.12 Affix label “To Be Cleaned” after completion of the operation and fill the “Equipment Log Book”.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department

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