Entry and exit procedure to production area

Entry and exit procedure to production area



Entry and exit procedure to production area

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 pharmaceuticals.
3.0   RESPONSIBILITY:

Ø     Production Manager
Ø     Assistant Manager Production
Ø     Production Pharmacist
Ø     Head of Operations
Ø     QA Manager
Ø     QC 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.
        1.Enter the buffer room from outside the building.
        2.Wash hands and face with soap.
         3. Enter the change area & wear the specified coat & cap.    
          4.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
 1.                                              Go to buffer room passing through exit door, take off coat and cap and deposit with the entrance.
 2.                                              Take off disposable shoe covers ( dispose off in dustbin) then leave through exit door to outside.

5.0     REVIEW FREQUENCY:

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


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