1.1 To lay down a standard procedure to be followed for disposal / returning of the leftover samples after study completion.
2.0 SCOPE
2.1 This SOP shall be applicable to the test item controller for handling the leftover sample after the study completed in the Department of Quality assurance (QAD).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 Procedure for Disposal of the leftover sample of test item
5.1.1 Destruction of the leftover sample after study completion (except archived quantity) shall be carried out in the presence of a test item controller, and head quality assurance.
5.1.2 Acids, bases, and other chemicals shall be treated accordingly to neutralize before disposing of (Chemicals treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent).
5.1.3 Wear gloves, nose masks during the destruction of the control sample.
5.1.4 Cut and open the polythene bag/vials and remove the material into a suitable glass container containing water/neutralizing solution.
5.1.5 Discard the resulting slurry to the wastewater disposal line carefully.
5.1.6 The opened polythene bag with defaced label shall be given to the housekeeping department.
5.1.7 Clean the area immediately after the destruction of the activity.
5.1.8 Destruction details like quantity destroyed, destroyed by, and checked by shall be recorded as per Format No.:- F……………………...
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1. |
Disposal
of leftover a sample of test item |
F……………….. |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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