SOPs

Entry & Exit procedure in warehouse area (RM), Sugar syrup area

Entry & Exit procedure in warehouse area (RM), Sugar syrup area

Objective

  • To lay down a procedure for the Entry & Exit procedure in warehouse area (RM), Sugar syrup area and liquid decortoning area through change room for  personnel and visitors.

Scope

  • This Standard Operating Procedure is applicable to all the  employees and visitors entering into the warehouse, sugar syrup and liquid decortoning area.

Responsibility

  • All personnel  shall be responsible for follow this SOP for the entry and exit to warehouse area (RM), Sugar syrup area and liquid decortoning area.

Accountability

  • Department Heads & QA Head shall be accountable for 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.
  • RM                              :            Raw Material
  • COB                            :           Cross over bench

Procedure

Entry & Exit procedure

Entry & exit procedure for personnel

Entry procedure from change room to RM, Sugar syrup & Liquid De-cartoning area

  • Push the door of primary change room and enter into the room.
  • Remove your street footwear and unwanted articles like wrist watch, ornaments etc. and keep them in respective lockers.
  • Sanitize your feet by using soak system having disinfectant.
  • Cross the cross over bench (COB) as displayed in pictorial.
  • Take your primary protective garments like company provided footwear, Cap and apron from the lockers & wear it accordingly.
  • Stand in front of mirror and ensure the completeness of the primary gowning.
  • Sanitize your hand with hand sanitizer.
  • Enter into internal passage and go to respective work place depending upon nature of job.

Exit procedure from RM, Sugar syrup & Liquid De-cartoning area

  • Pull the door and enter into the primary change room.
  • Remove your primary protective garments like apron and cap, company provided cleaned footwear put them in the respective lockers.
  • Cross the cross over bench (COB) as displayed in pictorial.
  • Wear your street footwear and take unwanted articles like wrist watch, mobile phone, ornaments etc.
  • Push the door and exit from primary change room.
  • Entry & exit procedure for visitors

Entry procedure from change room to RM, Sugar syrup & Liquid De-cartoning Area

  • Push the door of primary change room and enter into the primary change room.
  • Take shoe covers from the visitor locker.
  • Sit on the cross over bench (COB) and wear shoe covers as per pictorial displayed in change room.
  • Sit on cross over bench and cross it (COB) by swinging the legs upon the COB.
  • Take disposable apron & cap from the locker and wear it.
  • Stand in front of mirror and ensure the completeness of the primary gowning.
  • Sanitize your hand with hand sanitizer.
  • Enter into respective area.

Exit procedure from RM, Sugar Syrup & Liquid De-cartoning Area

  • Pull the door and enter into the primary change room
  • Remove apron and cap and put them in dustbin..
  • Sit on the cross over bench (COB) and cross the COB by swinging the legs.
  • Remove shoe covers and put them in dustbin.
  • Pull the door of primary change room.
  • Exit from primary change room.

Forms and Records (Annexes)

  • Not applicable

Distribution

  • Master copy –     Quality Assurance
  • Controlled copies –     Quality Assurance, Production, Quality Control, Engineering, HR &  Store

History

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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