Online Rejection in parenteral


Online Rejection in parenteral


1.1 To lay down the Procedure for Online Rejection in parenteral
2.0 SCOPE:
2.1 This SOP is applicable for Online Rejection at area
3.1 Officer / Executive – Concerned Department
4.1 Head – Production
5.1 Officer /Supervisor of concerned department shall be responsible for initiating on line rejection note.
5.2 Concerned department head/his designee shall be responsible for approval of online rejection note.
5.3 Officer / Executive QA shall be responsible for verification & confirmation of online rejection note.
5.4 Head QA /his designee shall be responsible for approving the rejection.
5.5 Store In-charge /his designee is the owner of the entire activity. He /She needs to keep a track of rejection

note and ensure that the CAPA is closed within one month.
5.6 Plant Head/his designee shall be responsible for implementation of this SOP.
5.7 QA Head/his designee shall be responsible for compliance of this SOP.
5.8 In case of raw material, packing material, fails in machine suitability during manufacturing and packing

operation, In-charge of concern department shall fill the online rejection note and shall submit to

department head / his designee for approval.
5.9 Officer / Executive QA shall submit online rejection note to QA head for approval.
5.10 On receiving the approved online rejection note from QA, concern department shall affix

filled “Online Rejection Label” on a consignment.
5.11 Warehouse department shall be forward the photocopy of online rejection note to QA department.
5.12 Online rejected material shall be consider as a rejected material and shall not be kept

along with approved material in warehouse.
5.13 A unique numbering system shall be followed for giving number to online rejection note;

for example :OLR/21/001
‘OLR’ stand for Online Rejection Note
‘/’ stand for separator
‘21’ stand for last two digit of the current year i.e., 21 for year 2021
‘001’ stand for serial number starting from 001.A new serial number shall be given for each calendar year.
5.14 Record the Online Rejection Record as per Annexure-II.
5.15 Record the Product/Material destruction Record as per Annexure-III.


Sr.No. Abbreviation used Full form of abbreviation used
1.  SOP Standard Operating Procedure
2. CAPA Corrective and Preventive Action
3. BMR Batch manufacturing Record
4. No. Number
5. BPR Batch Packing Record
6. QA Quality Assurance
7. OLR Online Rejection Note

Annex- I : Online Rejection Note
Annex- II : Online Rejection Record
Annex- III : Product/Material Destruction Record



                                                                                                                       Annex- I                                                                                       

                                                                                                      PARENTERAL INJECTION





Online Rejection Note No.
Details of Raw / Packing Materials:
Name of the Material:
Item Code
Name of the Manufacturer
Name of the Supplier
Batch No. / Lot No.
A.R. No.
Mfg. Date
Exp. Date
Date of Receipt
Quantity Received
Quantity Rejected
Reason for Rejection:



Initiated by Store In-Charge Department Head
Sign./Date Sign./Date Sign./Date
IPQA Remarks:


QA Officer / Executive






Plant Head / Director


QA HEAD Remarks:


QA Head/ Designee


STORE Final Disposal Details:
Materials destroyed at the site / return to the Supplier on:
CAPA of Supplier closed on:


Store In-Charge Plant Head QA Head
Sign/Date Sign/Date Sign/Date
Remark  *

Annex- II



S. No. OLR No. Date Product Name B. No. Mfg. Date Exp. Date Name of Rejected Material A.R. No. Total Qty. Received Total Qty. Rejected OLR

Prepared By

Approved By Remarks (if any)



Annex- III


Product/Material Destruction Record

S. No. Date Product/ Material Name Batch No. B. Size Mfg. Date Exp. Date Quantity / Unit for Destruction Reason for Destruction Remark


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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