Standard operating procedure for handling rejected or defective tablets.
1.0 Purpose
The purpose of this SOP is to establish a standard procedure for handling the non compliant rejected or defective tablets.
2.0 Scope
This SOP will be applicable for the procedure used for dealing with rejected or defective tablets at compression, coating or visual inspection stage.
3.0 Responsibility
- Machine Operator
- Area supervisor
- Production officer
- QA officer
4.0 Procedure
4.1 Identification of Rejected Tablets
4.1.1 The compression machine operator shall collect and segregate the initial quantity of tablets compressed during the machine adjustment put the label as rejected tablets along with the weight of the tablets and place them in the rejection bin.
4.1.2 The compression machine operator shall collect and segregate the quantity of tablets compressed at the end failing to meet the required weight and hardness specifications put identification label with weight of the tablets and place them in the rejection bin.
4.1.3 At the end of the compression process all the rejected tablets shall be checked by the production and QA officer & record the quantity in BMR and transfer it to the rejection holding area after preparing the disposal note.
4.1.4 The tablet coating operator shall remove any defective tablets (sticked,capped, twin, chipped) from the coating pan observed during the coating process and mark them as defective tablets and submit them in the rejection holding area as per above-mentioned procedure.
4.1.5 The visual inspection operator shall also collect the defective tablets after sorting and transfer them to the rejection holding area as per the above-mentioned procedure.
4.2 Disposal Of Rejected & Defective Tablets
4.2.1 The admin officer shall dispose of all the rejected and defective tablets by following the disposal SOP and record the activity.
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