Online Rejection in parenteral
1.1 To lay down the Procedure for Online Rejection in parenteral
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|
|5.||BPR||Batch Packing Record|
|7.||OLR||Online Rejection Note|
Annex- I : Online Rejection Note
Annex- II : Online Rejection Record
Annex- III : Product/Material Destruction Record
ONLINE REJECTION NOTE
|Online Rejection Note No.|
|Details of Raw / Packing Materials:|
|Name of the Material:|
|Name of the Manufacturer|
|Name of the Supplier|
|Batch No. / Lot No.|
|Date of Receipt|
|Reason for Rejection:
QA Officer / Executive
Plant Head / Director
QA Head/ Designee
|STORE||Final Disposal Details:|
|Materials destroyed at the site / return to the Supplier on:|
|CAPA of Supplier closed on:
ONLINE REJECTION RECORD
|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
|Approved By||Remarks (if any)|
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|