Standard Operating Procedure

For
Rejected Items and Returns
1.0 PURPOSE: To establish a documented procedure in handling of Returned and

Rejected Items.

2.0 SCOPE: This SOP is applicable shall be applicable for the handling of rejected and

returned goods together with defining the role/responsibility of various functions

responsible for handling of Returned / Rejected goods.

3.0 RESPONSIBILITY

3.1 QC personnel

3.2 QA personnel

3.3 Product personnel

3.4 Warehouse personnel

4.0 DEFINITION

4.1 Returned Items – The material which fails to meet the established

Specification, at the customer’s end or the material which does not meet the

customer’s specification. Also, it could be on the basis of breakage, damage

packaging, or any administrative aspect.

4.2 Rejected Items - means batches of Product or Pipeline Product which are

either (i) lost in production (or are not in compliance with the applicable

Specifications, cGMPs, the FDCA and any other applicable Legal

Requirements).

5.0 PROCEDURE

5.1 rejected material, QC chemist affixed the rejected label. Rejected material

transferred to the rejected room in presence of QA.

 5.2 On the basis of analytical observation of collected sample of raw material QC

personnel will prepare analytical report and affix status label either

approved or rejected on all the container of the material.

5.3 Rejected product/items will be ship to rejected section and it will be kept to

de-marketed area secured under lock and key.

5.4 Documentation of actions done on all rejected materials and goods must

always be presented.

6.0 PROCEDURE

Ensure that all returned products are handling in the following manner:

6.1 Returned goods shall be identified, identified and stored in designated area.

The stock will be placed in the Secured area under lock and key which is

adequately segregated and labeled as “Rejected Goods” and “ Retuned Goods”.

6.2 Defective or substandard products should not get mixed with good products.

6.3 Complete documentation is available on all operations.

7.0 RESPONSIBILITIES

7.1 Warehouse (BSR) personnel shall inform to Quality Assurance & Production

department about the receipt of returned finished goods and maintain the

records of returned goods.

7.2 Warehouse (BSR) personnel shall check all the documents and conditions of

return goods and shall store the returned goods as per the recommended

condition.

7.3 QC will collect sufficient sample (Sufficient to perform 3 analyses)

individually from each container if required or a representative sample from

all the containers as per the requirement of the parameters to be checked and
 also send the same sample to the external authorized autonomous

Laboratory.

7.4 The QC will test the material as per the laid down specifications.

7.5 An analytical Report with relevant details will be prepared by QC Executive

as well as by external laboratory to explore the possibilities of consideration for

reuse / destruction.

7.6 Based on the analytical report, GM – QA decides whether the returned good can

be reused or destroyed.

7.7 QA will monitor action plan throughout the operations till the returned good is

re- worked or disposed off.

7.8 QA case of destruction, the ‘Return good – Disposal record’ shall be filled in the

format and filed with QA along with Return Good – Assessment Report.

7.9 Documentation in every stage of the process is a must.

.8.0 ANNEXURE

Annexure: 1
Returned/ Rejected Goods Reports
Returned/ Rejected Goods Reports
Name of Product: _______________________
Batch no.: ______________________________
Mfg. date: ______________________________
Expiry date: ____________________________
Date of Rejection: ________________________
Date of Received Goods: ___________________
Received from: ___________________________
Reason of Rejection: ______________________
Return Goods Assessment Report:
__________________________________________
___________________________________________________
_____________________
Analysis report by Q.C Officer:
____________________________________________
___________________________________________________
_____________________
Return Goods Assessment Report:
Approved by Q.A Executive:           □ Yes        □ No
Precise action to be taken:
_________________________________________________
___________________________________________________
_____________________
Remarks by Manager Q.A:
________________________________________________
 
 
 
 
Prepared by Analysed by Authorized by
Officer Q.A Executive Q.A Manager Q.A