SOP on Entry and Exit into Sampling Booth Area

SOP on Entry and Exit into Sampling Booth Area

 Objective:

To lay down a procedure for entry and exit into sampling booth area.

Scope:

  • This procedure is applicable for entry and exit into sampling booth area

Responsibility:

  • QC Chemist or above

Accountability:

  • Head – Quality Control

Procedure:

Sampling Booth Area

Entry Procedure into Sampling Booth Area:

  • Break the seal of Area Cleaned to enter into personnel air lock area. Seal of Area Cleaned is as per Annexure No. A01 .
  • Take clean secondary gown.
  • Wear headgear and then wear secondary gown over the Primary gown.
  •  Wear booties.
  •  Enter into the Sampling booth area.
  • Hand gloves shall be used during sampling operation.

 Exit Procedure from Sampling Booth Area:

  • Before exit from sampling booth area discard the hand gloves in the waste bin.
  • Remove and keep Headgear, booties and secondary gown in the used gown bin.
  • Ensure sampling booth area has been cleaned
  • Exit through the personnel air lock.
  • Affix the seal of area cleaned as per Annexure No.01 .

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List of Annexure / Formats:

S.

No.

Format TitleAnnexure

Number

1Label for sealed AreaA01

References (if any):

Reason for Revision:

For better cGMP & cGLP

Abbreviation:

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

 

Annexure 1

Label for Sealed Area

 Sealed 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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