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:
| 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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