SOP on Cleaning of Sampling Booth Area

SOP on Cleaning of Sampling Booth Area

Objective:

  • To lay down a procedure for cleaning of sampling booth area.

Scope:

  • This procedure is applicable for cleaning of sampling booth area

Responsibility:

  • QC Chemist or above

Accountability:

  • Head – Quality Control

Procedure:

Cleaning of Sampling Booth

  • Clean Area with vacuum cleaner.
  • Wipe from top to bottom metal surfaces, Acrylic enclosures, balance etc. with a dry clean lint free cloth and inspect the same for any stains or unclean area.
  • All stains shall be cleaned with 0.2 % teepol solution with the help of scrubber like scotch brite or sponge and then with clean cloth wetted with purified water.
  • Mop floor and all metallic surfaces with a clean cloth wetted with 70 % IPA.
  •  Finally wipe all the surfaces with clean lint free cloth.

Cleaning of RLAF:

  • Clean the surface of RLAF cabinet before and after completion of each sampling with the help of dry lint free cloth followed by lint free cloth wetted with 70 % IPA.
  • Record all observations in “Sampling and Cleaning Record for Sampling Area” as per Annexure No. A01
  •  Exit from Sampling Booth  and affix the label of cleaned area as per Annexure No.A02 .

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List of Annexure / Formats:

S.

No.

Format TitleAnnexure

Number

1Sampling and Cleaning Record for Sampling AreaA01
2Label for cleaned AreaA02

 References (if any):

Reason for Revision:

For better cGMP & cGLP

Abbreviation:

  • SOP                      : Standard Operating Procedure
  • IPA                        : Isopropyl alcohol
  • QC                        : Quality Control
  • SG                         : Sub General
  • GMP                     : Good manufacturing practices
  • GLP                       : Good laboratory practices

 

   Annexure 1               

Sampling and Cleaning Record for Sampling Area

  LOCATION:                                                                         SAMPLING BOOTH ID No.:

SAMPLING RECORDCLEANING RECORD
DateMaterial

Name

A.R. NumberTimeSampled

by

Checked

by

TimeCleaned

By

Checked

By

Remarks
StartEndStartEnd
            

 

Annexure 2

Label for Cleaned Area

 Cleaned By/Date:

 Checked By/Date:

 

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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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