Entry & exit procedure in primary change room for personnel and visitors

Entry & exit procedure in primary change room for personnel and visitors

Objective

To lay down a procedure for the entry and exit in primary change room for  personnel and visitors.

Scope

This Standard Operating Procedure is applicable for all employees and visitors entering into the primary change room.

Responsibility

All employees and visitors of Pharmaceuticals Pvt. Ltd. shall be responsible for follow the procedure mentioned in this SOP.

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.

QA:Quality Assurance.

COB: Cross over bench.

Procedure

Entry & exit procedure for  personnel

Entry procedure from change room to primary production area.

Push the door of primary change room lobby.

Enter into the change room lobby and close the door of primary change room lobby.

Push the door of primary change room and enter into the primary change room.

Remove your street footwear and unwanted articles like wrist watch, ornaments etc. and keep them in respective lockers.

Wash your hands with liquid soap and dry under hand drier.

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, 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.

Then go to primary production area (Respective work place) depending upon nature of job.

Exit procedure from primary production 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 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. from respective locker.

Wash your hand with liquid soap and dry under hand drier (if applicable).

Push the door of primary change room lobby.

Enter into primary change room lobby.

Push the door of main entrance of production area.

Exit from primary change room.

Entry & exit procedure for Visitors

Entry procedure from change room to primary production area:

Push the door of primary change room lobby.

Enter into the change room lobby and close the door of primary change room lobby.

Push the door of primary change room and enter 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.

Cross the cross over bench (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 primary production area.

Exit procedure from primary production area

Pull the door and enter into the primary change room.

Remove apron and cap, 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.

Wash your hand with liquid soap and dry under hand drier (If applicable).

Push the door of primary change room lobby.

Enter into primary change room lobby.

Push the door of main entrance of production area.

Exit from primary change room.

Forms and Records (Annexures)

Not applicable

Distribution

Master copy – Quality Assurance

Controlled copies – Quality Assurance, Production, Quality Control, Engineering, HR & Warehouse

History 

    Date Revision Number                                      Reason for Revision
      –                 –                                           New SOP

 

 

 

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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