SOP for Overprinting of Batch Coding Details on Printed Packing Materials

Objective

The Objective of this SOP is to provide detailed instructions checking for overprinting of Batch coding details on printed packing materials.

Scope

The scope of the SOP shall apply to detailed procedures applied for Batch coding details are unique identifying marks that will allow tracking the history of the product that was manufactured in the respective area. The uniqueness has to be maintained in all primary and secondary packing materials with size and font in every batch that was manufactured. While printing these details have to be checked by the QA and Production Officer to avoid any discrepancies. This also follows important precautions while overprinting printed packing materials.

Responsibility

Performance: Worker, Operator, and Technician Responsible for performing the activity.

Checking: Production Supervisor, Technical Staff, and above to counter-check the activity.

Accountability

HOD: Production/Assigned Designee for Overall Implementation in the System with effective Procedural control to compliance.

HOD QA/Designee: Responsible for review, approval of the master document and compliance to the procedure in the production department.

Procedure

• Take line clearance before starting the overprinting from QA Officer.
• After getting printed packing materials from the packing material store, set the stereo in the stereo head and set the machine for alignment of overprinting details.
• Overprint the packing material and get the specimen for approval from the Production and QA Officer with signature Fill up the Batch Packing Record of overprinting and must be signed by the Production and QA Officer.

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• After getting approval starts the overprinting.
• Check the overprinted details like B.No. , Mfg. Dt., Exp. Dt., MRP etc., according to the BPR for every 30 minutes during the overprinting process and record in the B.P.R.
• Collect the overprinted packing material in previously labeled crates/boxes.
• After completion of overprinting close the crates with lids and boxes with tape.
• Then transfer these crates/boxes to the ‘printed packing material storage’ room and lock the room.

Precaution:

• Ensure that all printed packing materials of the previous batch has been removed from the overprinting area.
• Before issuing the stereo for overprinting, the stereo should be approved by Production and QA.
• The first overprinted specimen should be approved by the Production and QA Officer and those approved specimens should be attached to the B.P.R.

• Label all printed packing material and overprinted packing material with proper status labels.
• Start over printing after getting approval by the Production and QA Officer.
• Operate the machine as per the SOP.
• Overprinting should be neat & clean, clear and readable.
• Necessary precaution for safety concerns and others if applicable as required.

Acceptance Criteria:

• Only good intact, only neat & clean, clear and readable overprinted materials should go for packing.

Frequency: As and when required for operation is online.

Abbreviations

SOP: Standard Operating Procedure

BPR: Batch Packing Record

MRP: Maximum Retail Price

Q.A: Quality Assurance

HOD: Head of the Department

Annexure

Nil

Revision History

Nil

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