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QA SOP

SOP Title: Receipt, Storage and Handling of Finished Products

SOP Title: Receipt, Storage and Handling of Finished Products

  1. Objective:

To ensure that the finished goods are received, stored and handled carefully and systematically so that their identity, traceability and security are preserved.  It also defines and implements the procedure for despatch of the finished goods.

  1. Scope:

This procedure is applicable to Finished Products which are transferred from packing section.

  1. Responsibility:

Warehouse Department: To receive, verify, store, monitor the Finished Product as per this procedure.

QA Department: To prepare & approve procedure and ensure the compliance of the procedure.

  1. Accountability:

Head QA and Warehouse Department

  1. Procedure:

5.1  Definitions:

Quarantine: The status of materials isolated physically or by other effective means while a decision is awaited on their release, rejection or disposal.

Finished product: A finished dosage form, for example a tablet, capsule or solution that contains an active pharmaceutical ingredient, generally but not necessarily, in association with inactive ingredients in a final marketed pack.

 

5.2  Procedure:

5.2.1 Receipt of Finished Products/Goods  
5.2.1.1 On receipt of the Material transfer note in duplicate, the details of finished goods sent by Production Department shall be verified by comparing the actual stock against the details given in packed goods transfer note. The cases shall be examined for proper labelling, strapping and taping. Any discrepancy shall be brought to the notice of the Head of Quality Assurance for effective remedial action.  
5.2.1.2 The finished goods received from Production Department should be kept in the ‘Quarantine’ area.  
5.2.1.3 The Head Warehouse shall sign on the packed goods transfer note. The first copy shall be retained by the finished goods Warehouse, while second copy shall be returned to Production Department. Stock entry shall be made in the Material Control Record.   Both these entries shall be made on the date of receipt of the Finished Products.  
5.2.1.4 The Finished Products shall be transferred to the approved finished goods area after getting Batch Release from QA and arranged batch-wise in a manner to facilitate easy access to each batch and to facilitate dispatch of every product on First In First Out (FIFO) basis.  Entry to the Warehouse Department shall be restricted and the stock shall be under the custody of Head Warehouse all the times.  
5.2.2 Handling of Lorry Receipt and Invoice  
5.2.2.1 A copy of the customer’s order / invoice will be signed by Head Warehouse as verification of despatch of the correct goods.  A copy of the delivery note will be attached to the order copy and sent to Accounts Department for invoicing.  
5.2.3 Stock Posting  
5.2.3.1 Based on the invoice the entries of the despatch of the goods shall be made in the Finished Goods Stock Register/Software.  
5.2.4 Stock Statement  
5.2.4.1 Fortnightly stock statement of Finished Products (sales) shall be prepared and signed. Any discrepancy shall be brought to the notice of responsible Person.  Copy of the Stock Statement shall be sent to the management.  
5.2.5 Monthly Stock Statement  
5.2.5.1 Monthly Stock Statement of Finished Products (sales) should be prepared within one week after closing of the month. Checking, verification and distribution of the statement shall be done as per step 5.2.4.  
5.2.5.2 Physical stock verification of all products shall be done every month and the statement shall be signed confirming the correctness of the stock. Any discrepancy shall be brought to the notice of the responsible Person and Director.  

 

  1. Abbreviation:
QAP Quality Assurance Procedure
FIFO First In First Out

 

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

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