SOP for Entry and Exit Procedure for Executives, Staff, Visitors in Production Area

Objective

To lay down a procedure for Entry and Exit for Executives, Staff, and Visitors in the Production Area (gowning and degowning procedure).

Scope

This standard operating procedure is applicable for the entry and exit in the Production Block of a Pharmaceutical company.

Responsibility

• Executive / Staff / Visitors entering in production area shall be responsible for following the Entry and Exit procedure as per this SOP.
• The production head/designee shall be responsible for compliance of this SOP.
• Accountability: Production and QA shall be accountable for the compliance of this SOP.

Procedure

• Enter the changing room. Remove your footwear and keep in the shoe rack.
• Sit on the ‘Swing over bench’, lift both feet together, and cross over to the other side.
• The ornaments shall not be carried inside the production area and shall be kept in the locker provided.
• Clean the hands with the liquid disinfectant solution provided in the change room before entering into the production area.

• Visitors have to take primary gowning from the almirah and wear primary gowning (i.e. shirt, trousers, cap, and footwear/shoe cover) as displayed in the photograph hanging in the changing room. wear primary gowning (i.e. shirt, trousers, cap, and footwear/shoe cover) as displayed in the photograph hanging in the changing room.
• Executive and staff has to unlock the Locker, Wear your primary gowning (i.e. shirt, trousers, cap and footwear) kept in the locker provided as displayed in the photograph hanging in the change room. Check the tidiness of the primary gowning in the mirrors.
• Enter in the Outer corridor through the other door of the change room. A person with this primary gowning can access to all the areas except the core area.

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• For entry in the core area / secondary area, the person shall enter in the secondary gowning room of the respective Block. Secondary gowning rooms for entering Fab.-I, Fab.-II and Fab.-III, Liquid Oral Block and Gel / Ointment Block are provided separately. In secondary gowning cross the swing-over bench, clean the hands with Handy Clean Spray System containing 70% IPA in the secondary change room and wear secondary gowning of specified color as per respective area including snood and booty over the primary gowning before entering to the core area. Housekeeping personnel shall wear secondary gowning (i.e. protective gown, mask and shoe cover) over primary gowning. maintenance technician shall wear secondary gowning (i.e. secondary gowning, mask and shoe cover) over primary gowning. Color coding for Secondary Gowns.

• White Colour Secondary Gown – For Production Block Tablets, Capsule and Gel / Ointment Block.
• Cream Colour Secondary Gown – For Production Block containing Liquid Product.
• For exit from core area, remove secondary gowning (i.e. mask/snood, booty/shoe cover, hands gloves and secondary gown) in the secondary gowning room and cross the swing over the bench toward the exit door.
• Visitors, for exit from the production area, shall come back to the change room, remove primary gowning (i.e. shirt, trouser, cap, footwear) keep in the almirah over the hangers. Visitors shall wear a fresh dress on every entry into the production areas.
• An individual shall remove his secondary gowning for cleaning with every product changeover and at the end of every shift.
• Individuals remove /drop his primary gowning for cleaning at the end of every shift.
• For ease in sequential steps for gowning and degowning in the areas one can understand through the demonstrated photographs and can check the gowning in the mirrors.

Abbreviations and Definitions

Secondary Area (Core area): Area that comes in contact with the product directly for example Fabrication Room, Compression Room, Capsule Room, Coating Room, Blister Packing Room.

Primary Area: Area that does not come in contact with the product directly (outer corridor and Packing Hall)

Revision History

Nil

ALSO READ: SOP for Entry, Exit, and Gowning procedure for Powder Processing Area