by 1.0 OBJECTIVE
To lay down the procedure for Handling of sampling tools.
2.0 SCOPE
This procedure is applicable for the Handling of sampling tools used for the sampling activity in Quality control department .
3.0 RESPONSIBILITIES
Executive/ Officer QC shall be responsible for Handling of sampling tools .
Head-QC/ Designee shall be responsible for review and ensuring compliance of this Standard Operating Procedure.
4.0 DISTRIBUTION
Master copy : Quality Assurance Department
Controlled copy -1 : Quality Control Department
5.0 PROCEDURE
A unique identification number shall be allotted to each sampling tool as below :
GPL-ST-N,
Where;
‘GPL’ – Represents the Gracure Pharmaceuticals Limited.
‘‘ST’ – Represents ‘Sampling Tool’.
‘N’ – Represents the serial number of the sampling tool in two digits.
- Example: A sampling tool having serial number 01 shall be identified as GPL-ST-01.
- A label with the unique identification number shall be affix on the top of the sampling tool.
- A list of sampling tools shall be prepared and displayed at sampling tool storage area as per Annexure-1.
- Cleaning of Sampling Tools:
- QC Executive/officer shall collect the used sampling tool in a separate polyethylene bag after sampling of raw material.
- Affix the label “To Be Cleaned ” on the polyethylene bag.
- Wash the sampling tool with purified water till all the adhered materials are removed followed by 0.5 % teepol solution (Incase of sampling rod disassemble for washing)
- Wash the sampling tool with purified water again to remove any traces of teepol solution.
- Drain the water and dry the sampling tool using a lint free cloth.
- QC Executive/officer shall visually verify the cleanliness of sampling tool.
- After drying, wrap the sampling tool in a fresh polyethylene bag and affix “Cleaned” label .
- Cleaning of sampling tools shall be recorded .
6.0 ABBREVIATIONS
QC – Quality Control
QA – Quality Assurance
SOP– Standard Operating Procedure
