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SOP of Rejection of Packaging Material

This document outlines a procedure for handling rejected and obsolete packaging materials at a pharmaceutical company. It defines responsibilities for packaging material store personnel and quality assurance to implement the procedure. It describes rejecting materials at receipt if damaged, retaining rejected materials in a quarantined area, investigating line rejections from production, and destroying materials that fail retesting. The goal is to lay out clear steps for managing rejected packaging to ensure quality.

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6K views3 pages

SOP of Rejection of Packaging Material

This document outlines a procedure for handling rejected and obsolete packaging materials at a pharmaceutical company. It defines responsibilities for packaging material store personnel and quality assurance to implement the procedure. It describes rejecting materials at receipt if damaged, retaining rejected materials in a quarantined area, investigating line rejections from production, and destroying materials that fail retesting. The goal is to lay out clear steps for managing rejected packaging to ensure quality.

Uploaded by

Yousif
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Rejection of Packaging Materials

 Objective: To lay down a procedure for handling of obsolete / rejected printed


and unprinted packaging materials and line rejections.
 Scope: This procedure is applicable to packing materials store for
formulation plant of (Pharmaceutical Company Name).
 Responsibility:
o Packing material store personnel shall be responsible to follow

the procedure mentioned in this SOP.

o Packing material store in-charge shall be responsible for

implementation of the procedure mentioned in this SOP. 


 Accountability: Store & QA Head shall be accountable for the implementation
of this SOP. 
 Abbreviations and Definitions
o QA : Quality Assurance

o SOP :Standard Operating Procedure

o Obsolete :The packaging materials which are not in a state to be

of any further use.

o Rejected :The packaging materials which are not complying with

o Line Rejection :Approved material not able to be used during

operation for specified  reasons

 Procedure:
o Rejection of packaging materials at the time of receipt:

 Upon the receipt of Packing Material, verify it for any


damage, deface etc., if damage is observed to the extent
that can affect the quality of the Packing materials, the
material shall be rejected from the gate itself on the
Discretion of Packing Material Store In-charge and
Factory Manager.

 All unprinted Packing materials, if rejected after testing,


shall be kept in rejected storage area of Packing material
Store with “REJECTED” label duly filled and signed by
Packing Material Store In-charge and shall be sent back
to the supplier after proper documentation.

 On the receipt of the packing material the packing


material store incharge shall intimate to the QC Deptt.
for taking sample The QC Department shall take sample
of the packing material to confirm if the material
Supplied is as per the In-House specifications.

 If the sampled packing material complies with the In-


House specifications then the material shall be released
for consumption in packing of finished goods and
packing shall be labelled with the Status label of
“Released”.

 If the supplied packing material does not comply with


the In-House specification, the same shall be declaring
rejected material by the QC Deptt.

 QC Deptt. shall send the test report to packing material


store for taking necessary steps for Destruction or return
of the rejected material to the supplier, as the case may
be.

 Online rejection of packaging material:


o Rejections of packaging materials which are approved and issued

to production but rejected at line are termed as line rejections and


shall not be used in production for any specific reasons.

o When the rejected packing materials are received from

production, packing material store personnel shall verify the


quantity and reason for line rejection and keep all line rejections in
rejected area till a proper investigation is done by concerned
department and supplier.

o If the material is to be returned back to the supplier, the same

shall be done with proper documentation.

 Rejection of packaging materials at the time of retesting:


o The packaging materials, if rejected at the time of retesting shall

be kept in rejected storage area with a label “REJECTED” and to


be destroyed and documented duly filled and signed by the PM
Store In-charge.

o The rejected Packing Material shall be destroyed as per its SOP

after taking necessary approval from Managing / Executive


Director.

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