Warehouse

Handling of rejected materials

Handling of rejected materials

OBJECTIVE: To lay down a procedure for handling the rejected material in the warehouse.

SCOPE: This SOP is applicable for handling & disposal of rejected materials from the warehouse.

RESPONSIBILITY: Warehouse, QC, and QA personnel shall be responsible for following the procedure mentioned in this SOP.

ACCOUNTABILITY: The Warehouse In-Charge and QA Head shall be accountable for the compliance of the procedure mentioned in this SOP.

ATTACHMENTS 

  • Rejection intimation note
  • Destruction report 
  • Rejected finished product transfer note

PROCEDURE 

Any rejected material shall be transferred to the “Rejected material” area.

The rejected material area should be locked. WН in charge is responsible for keeping the key.

In case of any rejection, inform Quality Assurance and transfer the rejected material to the disposal area.

PRINTED PACKING MATERIAL REJECTION

Rejected printed packing material must be destroyed at the site.

If the rejected material is to be destroyed, then the destruction report has to be filled and the same should be approved by the QA Head and QC Head.

The destruction of the material should be conducted in the presence of the Warehouse in-Charge, Production Head, QC Head, and QA Head.

Before the destruction of any material, the vendor has to be intimated about the non-conformance of the material.

CONSIGNMENT REJECTION 

When a consignment has been delivered with critical defects (e.g. severe damages of secondary packing, damages of primary  packing integrity, etc.) The warehouse person should fill in the form (Attachment – I) and send it to the QC department.

If any consignment of material is non-conforming with the specifications, the consignment shall be rejected.

In case any consignment is rejected, the quality control shall send goods receiving note with a “REJECTED” seal to stores and the purchasing department. In turn, the purchasing department will intimate to the supplier about the rejection of the material.

Rejected material should be returned to the supplier.

FINISHED PRODUCT REJECTION 

The warehouse in charge monitors the shelf life of finished products. When the expiry date is due for products lying in the Warehouse or after receiving expired products from the market, those products shall be transferred to the disposal area.

The warehouse person should fill out the Rejected Finish Product transfer note and get the approval from the QA Head, Warehouse, Production, and Deputy General director.

In the Finish product register, the Warehouse person shall make an entry of details for the concerned product.

DISTRIBUTION LIST 

  • Quality Assurance Department
  • Warehouse Department
  • Quality Control

HISTORY OF REVISION 

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Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits 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. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube