sop for for Spillage Handling in parenteral area
1.1 To lay down the procedure for Spillage Handling.
2.1 This SOP is applicable for Handling of Spillage of all Substances and Products in Injection (Parenteral) Area
3.1 Officer / Executive – Production
4.1 Head – Production
5.1 As soon as spillage is observed, “Hold” the said Processing / Packing Operation and take needful corrective action to restrict further loss of RM, Production Bulk and primary Packing Material.
5.2 Inform the shift In-charge about the same, further they will intimate to the Department Head and Head QA.
5.3 If possible collect & check the weight of the spilled RM, Production Bulk and primary packing material.
5.4 For bulk solution concerned person shall be mop the spill solution and squeeze in separate container for weight loss.
5.5 Record the loss of quantity in respective BMR followed by its further approval from QA personnel.
5.6 In the event of bulk spillage during Manufacturing, Filtration and Filling, stop the spillage by closing the
valves of vessels having the bulk product.
5.7 In the event of product container’s breakage due to accidental fall, separate & collect the broken containers
in a Poly Bag. Handover the glass waste & paper waste to house keeping personnel.
5.8 Dilute the spilled RM / Product Bulk with sufficient Quantity of Water (Refer MSDS if required).
5.9 Drain the diluted Solution / Suspension / Slurry in the Drain System from specified Drain Points and
intimate ETP Personnel for its final disposal.
5.10 Undertake the cleaning of the area as per relevant sop
5.11 Raise the requisition for additionally required quantity of RM or PM (if any) on Material Requisition
note followed by approval from QA.
5.12 Proceed for further processing of the said batch. Prior to proceeding for filling and sealing send its sample
to QC and get its compliance reports as per relevant stage’s specification.
|Sr.No.||Abbreviation used||Full form of abbreviation used|
|1.||SOP||Standard Operation Procedure|
|2.||WFI||Water for Injection|
|3.||MSDS||Material Safety Data Sheet|
|4.||BMR||Batch Manufacturing Record|
|5.||ETP||Effluent Treatment Plant|
|7.||SOP||Standard Operation Procedure|
7.0 ATTACHMENTS (ANNEXES) : Nil