SOP on Visual Inspection of Filled Bottles

SOP on Visual Inspection of Filled Bottles
(Oral Liquids)

1.0 Purpose: This SOP describes the guidelines for the visual inspection to be carried out during the production (filling of bottles) of oral liquids.

2.0 Scope: This SOP applies to Quality Control Chemist, Production Chemist & Operating staff 

3.0 Responsibility:  It is the responsibility of the Production Chemist to ensure that the procedure is followed.

4.0 Materials and Equipment: Visual inspection unit with white & black back-ground. 

5.0 Procedure:
5.01 Hold 4 bottles (10 to 60ml fill) or 2 bottles (100 to 200ml fill) or 1 bottle (more than 200ml fill) in hand.
5.02. Gently shake the filled bottle(s) and keep in inverted position.
5.03 Check the contents of the liquid alternatively in white & black background and discard the bottles containing any visible particles.
5.04 Check for proper seal on bottles.
5.05 Check for any visible mark or crack on bottles.
5.06 In case of suspension, check for homogeneity of suspension.
5.07 Check that the volume of the filled contents in the bottle is not less or much more than standard / stated volume for bottles.
5.08 Recover the contents of bottles so rejected & record in the in-process control records.
5.09 Person(s) doing visual inspection should perform this operation for not more than 4 hours at a stretch and he / she should be periodically monitored for proper eyesight.

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