Scribd
Upload
41 views3 pages

Task: Proposed Change Description

Uploaded by

hdtarik
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
41 views3 pages

Task: Proposed Change Description

Uploaded by

hdtarik
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

Task: Implementation of pharmacode/barcode reader in packaging line

Proposed Change Description

Currently, our packaging process relies on manual verification of correctness of inner carton. It is
proposed to introduce a pharmacode/barcode reader which will automate this process, reduce human
error and prevent packaging material mix up.

Justification for Change

The implementation of a pharmacode/barcode reader in the packaging line is essential for compliance
with EU guidelines, enhancing accuracy, efficiency, and will ensure additional control over packaging
operation.

Scope of Impact

1. Packaging procedure (SOP, BPR)


2. Packaging material development by inclusion of pharmacode

Background Information

N/A

Primary Benefit

prevention of mix up: pharmacode/barcode reader ensure prevention of packaging materials mix-up,
packaging error, re-work and customer complaint.

Packaging control: pharmacode/barcode help ensure that the correct products are in the right packages
and distributed accurately.

Automation: pharmacode/barcode reader improve the efficiency of packaging through automated


packaging material verification.

Patient safety: pharmacode/barcode reader help ensure that patients receive the correct medications.

Regulatory compliance: Many regulatory agencies require pharmaceutical companies to use


standardized coding systems like pharmacode/barcode.

Acceptance Criteria (Action plan based on initiator’s assessment)

1. Preparation of URS for pharmacode/barcode reader.


2. Procurement, installation and qualification of pharmacode/barcode reader.
Task: Export Order Execution for Afghanistan market

Proposed Change Description

DBL pharmaceuticals Ltd. has received an export order of 17 products (List attached) from Afghanistan
market. The pack sizes of some of the products are different from the current configurations and
customized inner carton, leaflet are required by the customer. To execute the order, new packaging
components, including inner cartons, leaflets, and master shipper cartons need to be developed. A new
BOM and BPR with new FG code needs to be prepared for each of the 17 products to reflect the changes
in packaging components and quantities specific to the export pack sizes.

Justification for Change

The above changes are required to meet the customer demand. Afghanistan side wants customized pack
size and carton and leaflet with English language only (excluding bangla). So new packing items to
developed with new code. Also new FG code/BOM/BPR to be generated ensure proper tracking and
identification of the Afghanistan market products.

Scope of Impact

-The new Packing materials (carton, leaflet, master shipper carton) to develop with new item code.

-Purchase specification and QC testing specification of those packing materials need to be prepared.

-BOM and BPR to be created for Afghanistan market with new FG code.

-04 products are manufactured at toll site (Synovia & Beacon). So communication to be done with toll
site for the execution of this export order.

-Raw materials and packing materials to arrange to execute the order.

Background Information

International marketing department of DBL has explored the export market and grabbed an order from
Afghanistan. The customer wants 17 products from DBL site with new packing configuration.

Primary Benefit

The primary benefit of this change is the successful and compliant delivery of the full order to
Afghanistan, meeting their specific requirements and ensuring smooth operations without delays.

Acceptance Criteria (Action plan based on initiator’s assessment)


-New inner cartons, leaflets, and master shipper cartons for Afghanistan market to develop with new
artwork, size and item code.

-BOM and BPR to prepare of each 17 products with new FG code for Afghanistan market.

You might also like