To lay down an Entry and exit procedure for personnel into sampling booth area.
This procedure is applicable for entry and exit into sampling booth area.
QC Chemist or above
Head – Quality Control
5.0 Abbreviations and Definitions
SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
QC : Quality Control
SG : Sub General
GMP : Good Manufacturing Practices
GLP : Good Laboratory Practices
6.1 Entry Procedure into Sampling Booth Area:
6.1.1. Enter into the personnel air lock area.
6.1.2. Take clean secondary gown.
6.1.3. Wear headgear and then wear secondary gown over the Primary gown.
6.1.4. Wear booties.
6.1.5. Sanitize the hands, using disinfectant provided in the change room.
6.1.6. Enter into the Sampling booth area.
6.1.7. Hand gloves shall be used during sampling operation.
6.2 Exit Procedure from Sampling Booth Area:
6.2.1. Before exit, enter into the change room from sampling booth area and discard the hand gloves in the waste bin.
6.2.2. Ensure sampling booth area has been cleaned as per SOP No. QC-SG-012 (SOP on Cleaning of Sampling Booth Area).
6.2.3. Remove and keep Headgear, booties and secondary gown in the used gown bin.
6.2.4. Exit through the personnel air lock.
6.2.5. Status of the activity shall be mentioned on status board fixed on outside personnel air lock area as per Annexure No. (—–)
7.0 Forms and Records (Annexures)
Activity Status Label – Annexure -I
8.0 References (if any):
8.1 (SOP on cleaning of sampling booth area
Master copy – Quality Assurance
Controlled copies – Personnel & Administration, Quality Assurance, Warehouse RM (display & record).
|Date||Revision Number||Reason for Revision|
Annexure-I (Activity Status Label)
|Logo|| Company Name & Location
|Sign & Date|