Entry And Exit From Raw Material Sampling Area

Entry And Exit From Raw Material Sampling Area

November 28, 2019

Entry And Exit From Raw Material Sampling Area

Department : Quality Control

 SOP No: SOP/QC/003

Entry And Exit From Raw Material Sampling Area

Objective:
To lay down a procedure to describe the steps to be followed for entry / exit in the raw material sampling area.

 Scope:
This SOP is applicable to all employees entering in / exiting from the raw material sampling area.

 Responsibility:
Sampling Chemist.

 Accountability:
QC Head

Entry And Exit From Raw Material Sampling Area
Procedure:

 Entry In Raw Material Sampling Area
  1. Enter main production block through primary change room. 
  2. Enter to the raw material sampling area through change room.
  3. Remove shoes / slipper and place them in the shoe rack.
  4. Wear boiler suit for sampling area and Face-mask in the change room.
  5. Cross over the stainless steel bench. Wear sampling area footwear.
  6.  Enter in the raw material sampling area.
  7. In case if more than one exicipient is to be sample then gloves should be changed with
     the each exicipient.
  8. In case if more than one API is to be sampled,then the sampling gloves and boiler
    suit must be changed with the API.
Exit From Raw Material Sampling Area
  1. Remove the sampling area footwear.
  2. Cross over the stainless steel bench.
  3. Remove boiler suit for sampling area, face-mask and cap in the change room and wear footwear.
  4. Exit raw material sampling area.
  5. Exit out the production area through primary change room  

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