Drugsformulations

Issuance of Packing Materials and transfer of  Issued  materials from Packing Material Store to Production

Objective

• To lay down a procedure for Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production.

Scope

• This Standard Operating Procedure is applicable in Packing Material Store for Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production at formulation plant

Responsibility

• Packing Material Store & Production Personnel shall be responsible to follow the procedure mentioned in this SOP.
• Packing Material Store In-charge, Production & QA personnel shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability

• Packing Material Store In-charge & QA Head shall be accountable for the implementation of this SOP.

Procedure for Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production

Procedure

• On the receipt of the requisition slip from the concerned production personnel for the manufacture of a product, the store In-charge shall ensure that the requisition slip bears the signatures of all the concerned persons. Packing Material store in-charge shall take out the prints of the issue Note from ERP making simultaneous entries into the Packing Material Stock in ERP.
• The labels and other primary packing materials shall be issued by the In-charge of Packing Material Store only on the authorization of Quality Assurance Department.
• Packing Material Store In-charge shall issue the Packing Materials as per the Packing Material Issue Note generated through the ERP, which shall bear signatures of the store In-charge, QA Officer, Asst. Mfg. Chemist and Asst. Mfg. Supervisor.
• Store In-charge shall issue the Packing materials to the Production section as per the Requisition Slip and Issue Note generated through ERP.
• During the Issuance, Asstt. Mfg. Chemist, QA Officer and Store In-charge shall check each material for its:

1. Physical status of shipper / container / packing from which Packing material is to be issued.
2. Name of the material.

• AR. No.

1. Specifications (Item Code).
2. Product Name.
3. Batch No, if Printed.

• Labels, Cartons, Packing inserts, PP caps and all other materials to be issued in large quantities, where counting is difficult to be weighed on a balance and subsequently issued. In-charge Packing Material Store shall find out the average weight of unit material by finding the average weight of 100 units. Calculate the required weight to be issued by multiplying the average weight and quantity in numbers.
• Before starting the Issuance, In-charge Packing Material Store shall ensure that the weighing balances and surrounding area have been cleaned from all previous product / batch materials.
• Packing Material Store In-charge along with Asstt. Mfg. Chemist and QA Officer shall remain present at the time of weighing.
• Precaution shall be taken that only one item is dealt with at a time.
• After completion of weighing of a material, tag of the Packing Material shall be attached with each container containing the issued Packing material. All issued Packing materials shall be segregated batch wise.

• All issued Packing materials of a batch of a product shall be transferred in shippers / containers to the Respective Production Section and shall be kept on clean pallets in a secured place.
• Aluminium foil, PVC rolls are to be issued in excess weight, wherever issuing exact weight as given in Packing order is not practical. The weight issued in excess of the Packing requisition slip shall subsequently be returned by production department through “Material returned note” generated through the ERP to the Packing Material Store after Packing operations are over.
• Packing Material Store In-charge shall stock the printed labels of products (separately product wise) in a separate room.
• The printed labels shall be issued by the Packing Material Store In-charge in the presence of Quality Assurance Officer, who shall also sign the Issue note, prepared and signed by the Store In-charge and also signed by the Asstt. Mfg. Chemist.
• After finishing the labelling and packing of the batch of the concerned product, the Asstt. Mfg. Chemist shall entry the details in the PM reconciliation and destruction sheet attached in BMR in respect of the packing Material.
• The reconciliation format shall be reviewed by the Quality Assurance Department and any discrepancy in the labels etc., on which Batch Nos. etc. have been stamped or printed, shall be evaluated and shall be brought into the notice of the management and suitable action shall be taken in this regard.
• The unconsumed labels etc. on which Batch Nos. etc. have been stamped or printed which are returned to the Packing Material Store, shall be destroyed as per SOP titled “Disposal and Destruction of Material”, and shall not be stored with other labels / materials lying in the Packing Material Store.

Abbreviations and Definitions

• SOP                             :            Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
• QA                              :            Quality Assurance
• PM                              :            Packing Material
• BMR                           :            Batch Manufacturing Record
• PP caps                       :            Pilfer Proof caps
• PVC                            :            Poly Vinyl Chloride

Forms and Records (Annexures)

• Not Applicable

Distribution

• Master copy         –   Quality Assurance
• Controlled copies –   Quality Assurance, Packing Material Store, Production

History 

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