Entry Exit and Gowning Procedure in Dispensing Area
1.0 Objective
To lay down a procedure entry exit and gowning procedure in Dispensing area.
2.0 Scope
This Standard Operating Procedure is applicable for entry/exit and gowning procedure in Dispensing area to
be followed at formulation plants of A B C Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive warehouse shall be responsible to for the entry / exit and gowning
procedure in dispensing area.
3.2 Head Warehouse shall be responsible for implementation of this procedure.
3.3 Head QA or his designee shall be responsible for and compliance with SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
WH : Warehouse
5.0 Procedure
5.1 Entry Procedure
5.1.1 Open the door by pressing green button of door interlocking system and enter in to
the secondary change room of Dispensing area.
5.1.2 Remove the plant sleeper and put in the space provided in the cross over bench.
5.1.3 Cross over the bench to the other side.
5.1.4 Wear the hood and boiler suit. Ensure that the uniform not touching floor when wearing.
5.1.5 Wear the sleeper/ shoes dedicated for sampling area.
5.1.6 Wear nose mask, gloves.
5.1.7 Disinfect the hands using disinfectant solution provided (IPA 70% Solution) in the area.
5.1.8 Check yourself in the mirror for proper gowning.
5.1.9 Open the door of change room by pressing green button of door interlocking system
and enter into the Dispensing area.
5.2 Exit Procedure
5.2.1 Open the door by pressing green button of door interlocking system and enter the secondary change room.
5.2.2 Discard nose mask and gloves in the waste bin.
5.2.3 Remove shoes / sleeper dedicated for Dispensing area and then in respective place.
5.2.4 Remove the hood and boiler suit and keep then in respective place.
5.2.5 Cross over the bench and wear the plant sleeper.
5.2.6 Open the door by pressing green button of door interlocking system and exit out from the secondary change room..
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Warehouse Department.
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Entry Exit and Gowning Procedure in Dispensing Area