1.0   PURPOSE:

To ensure compliance of GMP for entry / exit in Production Area.

2.0    SCOPE:

This procedure applies to entry / exit of authorized personnel in production area of
Pharmaceutical.

3.0   RESPONSIBILITY:



Ø Production Manager
Ø Assistant Manager Production
Ø Production Pharmacist
Ø Head of Operations
Ø QA Manager
    
4.0    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 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.

5.0    QUALITY FORMS AND RECORD:

NA

6.0   DISTRIBUTION

·         Production Manager
·         Assistant Manager Production
·         Production Pharmacist
·         Head of Operations
·         QA Manager
·         QC Manager



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