Online Rejection in parenteral

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3 years ago

Online Rejection in parenteral

1.0 OBJECTIVE:
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
3.0 RESPONSIBILITY:
3.1 Officer / Executive – Concerned Department
4.0 ACCOUNTABILITY:
4.1 Head – Production
5.0 PROCEDURE:
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.

6.0 ABBREVIATIONS:

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

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

8.0 REFERENCES:

In-House

Annex- I

PARENTERAL INJECTION

ONLINE REJECTION NOTE

INITIATOR

DEPARTMENT

Online Rejection Note No.

Details of Raw / Packing Materials:

Name of the Material:

Item Code

GRN No.

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

Sign./Date

PLANT HEAD/

DIRECTOR

Remarks:

Plant Head / Director

Sign./Date

QA HEAD

Remarks:

QA Head/ Designee

Sign./Date

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

PARENTERAL INJECTION

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

Prepared By

Approved By

Remarks (if any)

Annex- III

PARENTERAL INJECTION

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