You dont have javascript enabled! Please enable it! WAR-040 Finished Goods Transfer to Quarantine and Distribution Warehouse Pharmaceuticals quality assurance & validation procedures GMPSOP

WAR-040 Finished Goods Transfer to Quarantine and Distribution Warehouse

DepartmentWarehouseDocument noWAR-040
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date: 

Document Owner

Warehouse Manager

Affected Parties

All production and warehouse staffs involved in transferring finished goods to Quarantine area and Distribution warehouse.

Purpose

To describe the procedure for transfer of Finished Goods from Production to the finished Goods Quarantine and from Quarantine to Distribution warehouse area.

Scope

The procedure set out below is to be followed by Authorised production and warehouse Operators.

Definition

BPNBatch Production Number
MI SheetManufacturing Instruction Sheet
GBSGoods Booking Slip
Pallet ID CardIdentification label of each pallet for a BPN

Related Documents

Form-210Goods Booking Slip
Form-215PARTIAL SHIPPER Sticker
Form-125Batch Reconciliation Sheet
Form-165Pallet ID Form
Form-085Released Sticker
Form-540Pallet Booking Information
MAN-125Sampling by Production Personnel for the Analytical Laboratory
MAN-080Example-Manufacturing Instruction for Tablet Packing

 

EHS Statement

Wrapping pallets on turntable

Procedure

1. Locations to Transfer

1.1. There is one (1) area of production from which finished goods will be transferred to Quarantine finished goods area.

WIP 4   Production WIP area 4

1.2. There is one (1) area of production from which returned materials/components will be transferred to warehouse bulk store.

WIP 3   Production WIP area 2

1.3. The Quarantine area will be used only for either

Storing incoming goods up to release by Laboratory

QIG QUARANTINE – (for in-coming goods) RECEIVING WAREHOUSE  OR

Storing Finished goods, completely separated from incoming goods, up to the release for distribution by Quality Assurance.

QFG QUARANTINE – (for finished goods) DISTRIBUTION WAREHOUSE

2. Goods Booking Out Procedure

On completion of packing of each pallet,

2.1. Take the In-Process Laboratory samples which will represent the total batch as specified in SOP MAN-125 and in the MI sheet

2.2. The production Operator will tally the count and produce a Pallet ID Form-165. Enter the pallet booking data into respective MI Sheet, Batch Reconciliation Sheet and on the Goods Booking Slip Form-210.

2.3. Ensure each pallet is identified with a Pallet ID Form-165 will have the following information.

Product code

Product Name

Batch Production Number

Production Line

Pallet number

Pallet Quantity

Two production operators will check the pallet for conformance, Sign and date the ID card.

2.4. Production operator has to assign a Goods Booking Number for each batch Production (BPN). Each GBS number is an eight digit number in the format of YYXXZZZZ, starting with the last two digits of the year, followed by a two digits of the month. A consecutive four digits number is assigned up to 1000 booking of batches started from 0001.

For example: GBS number for 10th delivery of the month of June year 2005 will be 05060010.

2.5. Fill up the “Production to Fill Up” section of the goods booking slip by writing product code, product name, BPN, process line, date, pallet number, last shipper number of the pallet, qty of the pallet.

2.6. Production operator who assemble the pallet should sign and date in the required section. One Authorised operator will check the lot and conforms by signing and date the GBS form. Print a copy of Pallet Booking Information Form (From-540) and enter the booking information on the form. Sign the form after entering each pallet data.

2.7. Place one copy of the “Goods Booking Slip” into a pouch. Attach the pouch securely to the base of the pallet identification card..

2.8. The pallet will be securely shrink-wrapped with the pallet card.  DO NOT attach tape to shipper itself, as this will cause the shipper to tear when removed.

2.9. Transfer the completed pallet into the WIP 4 area and contact warehouse staff to collect the pallets. The pallet will have the Pallet ID card and the Goods Booking Slip attached to it. The Laboratory samples, completed MI sheet, Batch Reconciliation Sheet and the Pallet Booking Information Record will be kept as a part of the batch Documents and send to Quality Assurance for checking for release.

2.10. The Warehouse operator will collect the pallet and check for conformance. Fill up the “Warehouse to fill Up Section” of the form. Write the date pallets are collected from the WIP 4 and transferred to Finished Goods Quarantine. The receiving operator will sign and date the receipt of the pallets. An authorised operator will check the lot and sign and date the receipt.

2.11. After the goods are moved to quarantine, warehouse operator has to write the storage bin and sign and date the GBS form.

2.12. The form will be kept in the warehouse office and completed by signing and date the movement from Quarantine to Finished Goods Store after QA will release the batch. “Released Stickers” From-085 will be provided by QA one per pallet for the BPN. Warehouse staff has to attach those stickers on the pallets before transferring to finished goods store.

2.13. The completed Goods Booking Slip will be kept in the warehouse file for future reference.

3. Last Pallet of an Operation

3.1. Production operator has to tally the count of the last shipper of the batch and enter on the MI Sheet. (See SOP WAR-080).

3.2. Ensure “Partial” shipper/box is marked with a “PARTIAL SHIPPER” sticker Form-215. Write the quantity of the partial shipper. Adjust the shipper label of the partial shipper with the actual quantity and sign the correction.

3.3. Ensure the pallet is identified with a Pallet ID card stating:

 – Product code

 – Product Name

 – Batch Production Number

 – Production Line

 – Pallet number

 – Partial Pallet Quantity

Two production operators will check the pallet for conformance, Sign and date the ID card.

NOTES

Separate Product Codes are to be held on separate pallets.

Part releases may be arranged before the completion of a batch.

Some EXPORT products may be ‘conditionally released’ to serve their quarantine period during shipment.

Should extra samples be required, the quantity on the identifying card must be adjusted. On completion of QC testing the batch is released

4. Summary of Changes

Version #Revision History
WAR-040New