sop for for Spillage Handling in parenteral area


sop for for Spillage Handling in parenteral area


1.1 To lay down the procedure for Spillage Handling.
2.0 SCOPE:
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
6. No. Number
7. SOP Standard Operation Procedure




Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel


sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area


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