This SOP show Complete Procedure Standard of Entry and Exit to Production Area is explained.

ENTRY/EXIT PROCEDURE TO PRODUCTION AREA SOP SCOPE:

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