SOP for inspection of uncoated tablets.

1.0 PURPOSE:

To lay down the procedure for inspection of uncoated tablets.

2.0 SCOPE:

SOP for inspection of uncoated tablets is applicable at production department of (Company name).

3.0 DEFINITIONS:

NIL

4.0 RESPONSIBILITY:

4.1 Production operator is responsible to follow the SOP. 
4.2 Production officer / executive is responsible for execution of the procedure.
4.3 QA officer / executive is responsible for ensuring line clearance.
4.4 Head-Production is responsible to ensure compliance of the procedure.

5.0 PROCEDURE:

5.1 Pre-operation checks: 
5.1.1 Inspection activity shall be performed by wearing the pressure suit.
5.1.2 Before taking tablet for the inspection, verify the gross weight, Net weight and tare weight of the containers.
5.1.3 Ensure the acrylic cabinet is fixed and visually check the integrity of the gloves of the inspection gloves.
5.1.4 Check the cleanliness of area as well as tablet inspection belt.
5.1.5 Take line clearance and affix the status label.
5.1.6 Bring the uncoated tablet container in inspection area.
5.1.7 Attach the tablet collection container or HDPE drum at discharge chute of tablet inspection belt.
5.2 Operation Procedure:
5.2.1 Turn the belt “ON/ OFF” switch to ON mode to start the conveyor belt.
5.2.2 Adjust the speed of the conveyor belt by rotating the knob of belt.
5.2.3 Turn the vibrator “ON/ OFF” switch to ON mode.
5.2.4 Adjust the vibrations by rotating the knob of vibrator.
5.2.5 Load the tablets into the hopper.
5.2.6 Adjust the height of the belt for tablet movement control with respect to size of tablet.
5.2.7 The tablets will be flow on conveyor and collected into HDPE or collection container connected at discharge.
5.2.8 If any rejects found, press and hold the foot switch to stop the conveyor belt.
5.2.9 Collect the rejected tablets with the help of gloves and put it into rejected bin.
5.2.10 Release the foot switch, the conveyor belt will be start.
5.2.11 Collect the rejected tablets from rejected bin into poly bag and take it to outside for deactivation.
5.2.12 Inspection shall be done only by qualified visual inspectors.
5.2.13 Personnel should have a break time of 10 minutes in every hour inspection. Inspectors can be changed in that time.
5.2.14 Two persons shall do the visual inspection at a time.
5.2.15 During inspection make a note that both rear and front side of the tablet should be inspected. Person who is seeing the top side of the belt will see the front side of the tablet and person who is seeing the bottom side of the belt will see the rear side of the tablet.
5.2.16 Following defects to be sorted out during inspection but not limited to.
• Excess surface powder
• Foreign particles
• Sticking.
• Chipped tablets
• Capped tablets
• Picked tablets.
• Broken / Brittle tablets.
• Lamination.
• Double impression.
• Punched ends.
• Large specks : Easily noticeable spot
• Colour variation: Colour of tablets significantly different from other tablet
• Missing imprint (if applicable)
• Porous surface.
• Cracked tablets.
• Break line tablets.
• Illegible debossing.

Note: If any of the above defects is observed during tablet manufacturing then batch shall be inspected before packaging.
5.3 Affix the ‘STATUS’ label to the inspected tablet and rejected tablets as ‘REJETED’.
5.4 Destroy the rejected tablet as per destruction procedures.

6.0 ABBREVIATIONS:

SOP: Standard Operating Procedure. 
IPC: Inprocees product container
HDPE: High density polyethylene

7.0 REFERENCES:

NIL

8.0 LIST OF ANNEXURES:

NIL

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