Entry & Exit procedure in secondary change room
Entry & Exit procedure in secondary change room
Objective
- To lay down a procedure for the entry and exit in the second change room
Scope
- This Standard Operating Procedure is applicable to all the parma industries employees and visitors entering into the manufacturing area.
Responsibility
- All personnel working in Torque Pharmaceuticals Pvt. Ltd. shall be responsible for following this SOP for the entry and exit in the second change room.
Accountability
- Department Heads & QA Head shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
- SOP: Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
- QA: Quality Assurance.
- COB: Cross over Bench.
Procedure
Entry procedure for the secondary change room
- Open the door of the second change room.
- Enter the change room and close the door of the second change room.
- Collect your secondary garments from the cabinet
- Sit the cross over the bench and cross the Cross over Bench (COB).
- Wear the headgear.
- After then wear the secondary gown.
- Stand in front of the mirror and ensure the completeness of the secondary gowning.
- Disinfect your hand.
- Open the door and enter the respective area.
Exit procedure from secondary change room
- Open the door of the second change room.
- Enter into the secondary change room.
- Remove secondary garments.
- Remove headgear.
- After then sit on the cross-over bench and remove booties.
- Cross the COB.
- Drop the used secondary garments in the used garments bin.
- Exit from the secondary change room.
Note: All visitors shall follow the same procedure using disposal garments.
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Forms and Records (Annexures)
Not applicable
Distribution
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Engineering, HR & Warehouse
History
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