SOP on Entry and Exit into Sampling Booth Area

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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 Title Annexure

Number
1 Label for sealed Area A01

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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