Drugsformulations

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:

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:

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

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