SOPs

Operation and Cleaning of Refrigerator

Operation and Cleaning of Refrigerator

Objective

  • To lay down a procedure for Operation and Cleaning of Refrigerator in Raw Material Store.

Scope

This Standard Operating Procedure is applicable for operation and cleaning of Refrigerator in Raw Material Store at formulation plant of  Pharma Company.

Responsibility

  • Raw material Store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Raw material Store in-charge shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability

  • Raw material Store In-charge & 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
  • Ltd. :     Limited
  • RM  :     Raw material

Procedure

Operation of Refrigerator

  • Refrigerator is leveled with suitable means.
  • Ensure plug and socket have proper connections.
  • Switch ‘ON’ the main supply and open the refrigerator door to check room lamp.
  • Adjust the thermostat to the required extent by thermostat knob and thereby the temperature is maintained between 2 and 8º C.
  • Locate a calibrated thermometer in refrigerator.
  • Ensure tight closure of refrigerator door.
  • Expose the thermometer for a minimum period of 15 Minutes.
  • Open refrigerator door to remove thermometer.
  • Check the temperature immediately.
  • The temperature inside the refrigerator should be not more than 8°C.
  • When the temperature is found out of the limits (above 8°C) shift all the material into another refrigerator and inform head of the department and QA.
  • Inform the engineering department for necessary action.
  • The refrigerator must not be overcrowded at any time.

Cleaning procedure for refrigerator

  • Refrigerator should be cleaned weekly or as when required.
  • Switch off the mains of the refrigerator.
  • Remove all the items from the refrigerator and put them in other refrigerator, clean with the warm Purified water.
  • Replace all the required items and arrange them properly.
  • Ensure every item is labeled properly.
  • After completion of cleaning, record the cleaning time in their log book.
  • Fix the ‘Cleaned’ label on the refrigerator.

Forms and Records (Annexures)

  • Not Applicable

Distribution

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

History 

DateRevision NumberReason for Revision
                                   New SOP

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