1.0 Purpose

To lay down the procedure for the safe, secure, and documented transfer of finished goods from the production/packing area to the bonded store room under controlled conditions to ensure compliance with regulatory and company requirements.

2.0 Scope

This procedure is applicable to all finished goods that are transferred from the production/packing department to the bonded store room of [Company Name].

3.0 Responsibility

• Production/Packaging Department:

  • Ensure finished goods are packed, labeled, and quarantined properly before transfer.

  • Hand over finished goods with proper documentation.

• Warehouse/Store Personnel:

  • Verify received goods against documentation.

  • Store the goods in the bonded store room under appropriate storage conditions.

• Quality Assurance (QA):

  • Verify transfer records.

  • Ensure compliance with cGMP and GDP requirements.

4.0 Procedure

4.1 Pre-Transfer Checks

• Ensure finished goods are released by QC (for packaging) and QA (for batch clearance).

• Verify that the goods are packed as per SOP and bear proper labeling (product name, batch no., Mfg. date, Exp. date, pack size, storage conditions).

• Ensure goods are in quarantine area before transfer approval.

4.2 Documentation

• Prepare the Finished Goods Transfer Note (FGTN) containing:

  • Product Name

  • Batch Number

  • Quantity (No. of cartons/units)

  • Manufacturing Date & Expiry Date

  • Storage Conditions

  • Dispatch Authorization Signatures (Production Head / QA Head)

4.3 Transfer to Bonded Store

• Store personnel shall arrange for clean, dedicated trolleys/pallets/forklifts for transfer.

• Transfer goods under controlled conditions (temperature, humidity if applicable).

• Bonded store in-charge shall check and receive goods against FGTN.

4.4 Storage in Bonded Store Room

• Place goods in designated and labeled bonded storage area.

• Follow FIFO/FEFO system.

• Maintain segregation between quarantined, released, and rejected stock.

• Update Bonded Store Stock Register or ERP system immediately after receipt.

4.5 Post-Transfer Compliance

• Ensure restricted access to bonded store room (authorized personnel only).

• Maintain environmental conditions as per product requirement (record temperature & humidity).

• Keep records of all transfers for audit and regulatory compliance.

5.0 Records

• Finished Goods Transfer Note (FGTN)

• Bonded Store Stock Register / ERP Entry

• Environmental Monitoring Records of Bonded Store

6.0 Abbreviations

• SOP – Standard Operating Procedure

• QA – Quality Assurance

• QC – Quality Control

• FGTN – Finished Goods Transfer Note

• FIFO – First In First Out

• FEFO – First Expiry First Out

7.0 References

• cGMP Guidelines (WHO, USFDA, EU GMP)

• Company Quality Management System Manual

8.0 Annexures/Formats

• Annexure I: Finished Goods Transfer Note (Template)

• Annexure II: Bonded Store Stock Register Format

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