To restrict entry of unauthorized Person in the Store

To restrict entry of unauthorized Person in the Store

Objective

  • To lay down a procedure to restrict entry of unauthorized Person in the Store.

Scope

  • This Standard Operating Procedure is applicable at Store at formulation plant

Responsibility

  • Store in-charge/personnel shall be responsible to follow and implementation of the procedure mentioned in this SOP.

Accountability

  • Store Incharge & 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
  •  Deptt.  :         Department

Procedure

restrict entry

  • List of Authorized persons to enter in store duly approved by QA shall be displayed on the front main gate of the store.
  • Indicate “ENTRY RESTRICTED” on the entry doors of all the store areas with paint.
  • Anyone who is not authorized cannot enter the warehouse area with authorized person without any valid reason
  • Properly lock the store.
  • Open the lock when required only in the presence of store personnel.
  • It is necessary for the person who is entering the store to wear the protective garments.
  • In Raw Material Store, shift the required raw material in the dispensary in the presence of store personnel and lock the store immediately. Return the material containers from the dispensary to the store after completing the process.
  • In Packing Material Store, transfer the required Packing Material to the production in the presence of store personnel and again lock the store immediately. Return the excess packing material from the production to the packing material store after completing the process.
  • In Finished Goods Store, transfer the required Finished Goods dispatched from the store under supervision of store personnel and again lock the store immediately.
  • The store personnel shall keep the keys of store very carefully with full responsibility.

 Forms and Records (Annexures)

  • Not Applicable

Distribution

  • Master copy         –          Quality Assurance
  • Controlled copies     –           Quality Assurance, Store

History

 

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 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, Panacea Biotec Ltd, and Nectar life Science 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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