sop for for Spillage Handling in parenteral area
1.0 OBJECTIVE:
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
3.0 RESPONSIBILITY:
3.1 Officer / Executive – Production
4.0 ACCOUNTABILITY:
4.1 Head – Production
5.0 PROCEDURE:
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.
6.0 ABBREVIATION:
| 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 |
7.0 ATTACHMENTS (ANNEXES) : Nil
8.0 REFRENECES:
In-House
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 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
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 operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
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
