Standard Operating Procedure of Handling Returned/ Rejected Goods in Pharmaceuticals Plant is describe in this post.
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1.0 OBJECTIVE:
To lay down the documented procedure for handling of Returned/ Rejected Goods.
2.0 SCOPE:
This SOP shall be applicable to define role/ responsibility of various functions responsible for handling of Returned/ Rejected Goods.
3.0 RESPONSIBILITY:
3.1 Officer/ Executive/ Assistant Manager.
4.0 ACCOUNTABILITY:
4.1 Head of Quality Assurance Department.
4.2 Head of Production Department.
4.3 Head of Quality Control Department.
4.4 Head of Store Department.
5.0 PROCEDURE:
5.1 Ensure that all returned products are handling in the following manner:
5.1.1 There are no mistakes in identity for products and batch numbers.
5.1.2 Defective or substandard products should not get mixed with good products and become liable to be offered for sale.
5.1.3 The handling and disposition of returned products should not contravene any statutory requirements.
5.1.4 Complete documentation is available on all operations on returned products from receipt to final disposal.
5.2 Any goods which have returned from the market for any one of the following reasons are treated as a returned good.
5.2.1 Return goods on advice of Drug Control / Regulatory Authorities from the market customers.
5.2.2 Returned stock from distribution office, due to:
5.2.2.1 Date Expired Products.
5.2.2.2 Damaged of Broken Primary containers.
5.2.2.3 Leaky or Broken Seals of Closures of Primary Containers.
5.2.2.4 Mutilated or smudged labeling rendering the product unidentifiable of its name, or batch number.
5.2.2.5 Soiled labeling rendering the products unassailable or un-presentable aesthetically, but otherwise clearly identifiable for product name and batch number.
5.2.3 Returned goods for any voluntary reason.
5.2.4 Returned goods for any impairment in analytical report reported by customer.
5.3 The returned goods will be received by Finished Goods Warehouse. The stock will be placed in the Secured area under lock and key which is adequately segregated and labeled with the reason for return as per the reasons mentioned in above, by Assistant-Finished goods Assistant/Sr. Executive-Production.
5.4 A description of the condition in which the goods will be entered in the Returned Good-Assessment Report by Assistant-Finished goods/ Sr. Executive Production.
5.5 The returned Good-Assessment Report will be sent to QA Executive. QA Executive will physically inspect the condition of the returned goods and enter his observations in the Returned Good-Assessment Report and send the report to GM-QA.
5.6 Based on the above observation, GM-QA will decide whether:
5.6.1 Re-analysis is required to consider for reuse or rectification.
5.6.2 The material should be destroyed.
5.7 If re-analysis is required, the QA Executive will send the Returned Good Assessment Report to QC Executive for arranging for sampling and analysis of the material.
5.8 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.
5.9 The QC will test the material as per the laid down specifications.
5.10 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.
5.11 Based on the analytical report, GM –QA decides whether the returned good can be reused or destroyed.
5.12 The Return Good-Assessment Report will be approved by GM-QA.
5.13 The Report is then sent to the Ware House-Manager who will prepare and coordinate for the action plans drawn. The action plan should be approved by GM-QA.
5.14 QA will monitor action plan throughout the operations till the returned good is re-worked or disposed off.
5.15 In case of destruction, the ‘Return Good – Disposal Record’ shall be filled in the format and filed with QA along with Return Good-Assessment Report.
5.16 The Product Assessment Report along with Return Good Assessment Report should be sent to G.M-Plant for his authorization and the same shall be filed with QA.
6.0 ANNEXURES:
Annexure 1:
Returned/ Rejected Goods Reports.
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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:
____________________________________ ____________________________________________________________
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