You dont have javascript enabled! Please enable it! WAR-055 Work in Progress Area Pharmaceuticals quality assurance & validation procedures GMPSOP

WAR-055 Work in Progress Area

DepartmentWarehouseDocument noWAR-055
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date: 

Document Owner

Warehouse Manager

Affected Parties

All warehouse staffs working in the dispensing operations.

Purpose

To describe the purpose and use of the Work-In-Progress (WIP) area.

Scope

The overall responsibility to maintain this SOP is for the Warehouse Manager. This SOP will be followed by Warehouse Operators on day to day operations.

Definition

QFGQuarantine Finished Goods
QIGQuarantine In-coming Goods
Slip sheetSpecially prepared cardboard used on the top of empty pallet.

 

Related Documents

Form-015Warehouse Information Form
MAN-040Waste or Rejects Removal – Manufacturing Facilities
MAN-005Clothing Requirements Inside the Factory Areas

 

EHS Statement

Safety Glasses and gloves must be worn when using IPA.

1. General

1.1. WIP areas are critical areas, as a constant flow of waste and returns from production are going down to the Warehouse through WIP 3, all finished goods from production are going down to the QFG through WIP 4, and issues are coming up to the process lines through WIP 1& 2 .

1.2. All Returns are to be passed straight away to warehouse, not left in WIP. All Finished Goods are to be passed straight away to quarantine finished goods (QFG).

1.3. The Work-in-Progress (WIP) area is predominantly used for temporary storage of Finished goods, materials, components, validation work-in progress, or temporary machine storage.  Also within the WIP area will be holding bays for temporary storage of Issues-for-Production components.

1.4. Good Housekeeping is vital in running the WIP area efficiently.  Please treat this area in this manner by keeping floors clean, removing rubbish, pallet jacks, bins, and other items belonging elsewhere.

1.5. The WIP area is a “D” Grade area and “D” Grade clothing requirements must be met.
Details for clothing requirements are covered in SOP MAN-005

2. Procedure – WIP area

2.1. All product and other materials must be properly secured. Pallets are marked using a Warehouse Info Form Form-015.

2.2. Any items entering the production area from WIP 1 & 2 must first be cleaned, (i.e. remove dirty wrapping or use disposable wipes and 70% IPA as necessary).

2.3. As much as possible the aisle must be kept clear of pallets and other items.  These items are otherwise unsafe and cause great inefficiency in operating the WIP area. The floor also marked with arrows indicating the direction of incoming/outgoing goods.

3. Slip-sheet Storage

3.1. Slip-sheets for batch productions are stored in WIP 3, so when a production line requests packaging materials through Material transfer Orders for their batch the slipsheets are readily accessible from one central area.  This area is replenished by the Warehouse team. if there are any problems or shortages contact the Warehouse operators.

3.2. Slipsheets are placed into WIP area from the Warehouse bulk store locations after being issued for a BPN. An authorized warehouse personnel is responsible for ensuring there is an adequate supply of all slipsheets at all times.

4. Waste Handling in WIP

Bins must be wiped clean with mild cleanser and with disposable wipes if they have entered into a Grade “E” area and are in need of cleaning, before re-entering into production.  This is to be carried out by the Warehouse staff when needed. Waste is disposed of as per SOP MAN-040.

5. Pallet Information in WIP

The Warehouse will not accept any pallets/items into the Warehouse without having a Warehouse Info Form (Form-015) completed and attached to all goods.

6. Summary of Changes

Version #Revision History
WAR-055New