sop of Rejection of Packaging Materials

sop of 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:
    • Packing material store personnel shall be responsible to follow the procedure mentioned in this SOP.
    • 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
    • QA : Quality Assurance
    • SOP :Standard Operating Procedure
    • Obsolete :The packaging materials which are not in a state to be of any further use.
    • Rejected :The packaging materials which are not complying with
    • Line Rejection :Approved material not able to be used during operation for specified  reasons
  • Procedure:
    • 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:
    • 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.
    • 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.
    • 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:
    • 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.
    • The rejected Packing Material shall be destroyed as per its SOP after taking necessary approval from Managing / Executive Director.
  • Handling of obsolete Packaging Materials:
    • Printed Packing Materials shall be considered as obsolete when there is a change on packaging material w.r.t. revision of art work, marketing or regulatory requirement or otherwise not fit for use in the packing of finished Products.
    • The obsolete packaging materials shall be kept in rejected area under lock and Key bearing label of Rejected Materials.
    • Materials, which are lying in store and not in a condition for further use, shall be destroyed as obsolete materials after taking approval from Head – Warehouse, Manager – Q.A. and Managing / Executive Director GM.
    • Proper entries shall be made in “packaging materials stock register” and information shall be sent to Excise department (if applicable) to get the entries done in their respective records for the material to be destroyed.
    • After counter checking the materials shall be destroyed in presence of officer or above –Warehouse, Quality Assurance, if required.
    • After destruction authorized personnel shall sign the destruction note.
  • Forms and Records (Annexures): Not Applicable
  • Distribution
    • Master copy – Quality Assurance
    • Controlled copies – Quality Assurance,Raw Material Store,Packing Material Store
  • History
Date Revision Number                            Reason for Revision
                                   New SOP



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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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