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SOP on Repacking of Finished Product

1.0 Purpose: To lay down the procedure for Repacking Of Finished Product.

2.0 Applicable: This Standard Operating Procedure is applicable to the repacking of the finished product on the production floor.

3.0 Responsibility:

3.1 Asst. Manager/ Sr. Officer / Officer of the production department shall execute this SOP.

3.2 Manager / Sr. Manager Shall supervise that the process is being followed as per SOP.

3.3 Head-Quality Assurance/designee shall be responsible for ensuring the compliance of this SOP.

4.0 Safety considerations:

4.1 Cold chain shall be maintained during the complete repacking process

5.0 Procedure:

5.1 Repacking and relabeling activity shall be taken up in case of special consideration, for example:

1. If the baby shipper is damaged

2. PP band is damaged

3. Mono carton damaged

4 Any other condition in which market requirement or regulatory requirement needs to be considered by repacking the existing finish goods.

5.1.1 Production shall initiate repacking requisition to QA as per Annexure-1

5.1.2 Check the quantity (to be repacked) physically and mentioned in the BPR.

5.1.3 Send the requisition to Warehouse for issuance of secondary packaging material (duly signed by QA)

5.1.4 Start the repacking and fill the BPR as per SOP

5.1.5 Transfer the repacked batch to the Warehouse.

5.1.6 Then reconcile the packaging material and destruct the rejected/damaged material on a destruction note.

5.1.7 QA shall review the reconciliation and shall perform quality impact/regulatory impact, and shall approve the same.

5.1.8 QA in charge shall issue the packing part of the BPR to production.

5.1.9 The repacking activity shall be done after line clearance, and IPQA shall monitor the activity.

5.1.10 The changed packing material shall be discarded and transferred to the scrap area as per SOP.

5.1.11 The repacking BPR shall be handover to QA.

Related: SOP on the operation of strip pack machine

Abbreviations:

HOD: Head of the Department

QA: Quality Assurance

SOP: Standard Operating Procedure

IPA: Isopropyl alcohol

No. : Number

ID no. : Identification number

ANNEXURE-1:

repacking annexure

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