This SOP show Complete Procedure Standard of Entry and Exit to Production Area is explained.
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ENTRY/EXIT PROCEDURE TO PRODUCTION AREA SOP PUPOSE:
To ensure compliance of GMP for entry/exit in Production Area.
SCOPE
This procedure applies to entry / exit of authorized personnel in production area of Pharmaceutical.
RESPONSIBILITY
Production Manager
Assistant Manager Production
Production Pharmacist
Head of Operations
QA Manager
PROCEDURE
Production area entry / exit is through three separate entry / exit points
Male worker entrance
Female worker entrance
Executive & visitors entrance
Entry procedure for workers is described in sequence as under.
Enter the buffer room from outside the building.
Wash hands and face with soap.
Enter the change room & change the street cloth with specified work uniform.
Take off the street shoe, step over the step over bench & wear the clean shoe & enter the production Area.
Entry procedure for Executives / visitors is as follow.
- Enter the buffer room from outside the building.
- Wash hands and face with soap.
- Enter the change area & wear the specified coat & cap.
- Take off the street shoe, step over the step over bench & wear the clean shoe & enter the production Area or wear the disposable shoe covers over street shoes.
Exit procedure for workers described in sequence as under
- Go to the buffer room through exit door,
- Take off work shoes & wear street shoes then go to change room.
- Take off the work uniform & store it in the locker.
- Wear street cloth and leave for outside.
Exit procedure for executives / Visitors is as follow
- Go to buffer room passing through exit door.
- Take off coat and cap and deposit with the entrance.
- Take off disposable shoe covers (dispose off in dustbin) then leave through exit door to outside.
DISTRIBUTION
- Production Manager
- Assistant Manager Production
- Production Pharmacist
- Head of Operations
- QA Manager
- QC Manager
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