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.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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About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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