1.0 PURPOSE:
To lay down a procedure for Disposal of all types of samples after testing excluding Microbiology.
2.0 SCOPE:
This SOP for disposition of analytical samples covers Disposal of all types of samples after testing excluding Microbiology of quality control laboratory of (Company name).
3.0 DEFINITIONS:
Nil
4.0 RESPONSIBILITY:
4.1 Quality Control Analyst follows the destruction procedure as per the SOP.
4.2 Department Head/designee quality control for compliance of this procedure.
5.0 PROCEDURE:
5.1 Disposal:
5.1.1 Deface the labels on containers of Raw Material, In-Process and Finished Product samples and samples of Printed Packaging Material by drawing a cross (X) over the entire label after the completion of analysis and reporting.
5.1.2 Keep samples at designated place allocated for each category of samples, which are labeled and identified as “Samples for Disposal”.
5.1.3 Remove samples from designated storage at a frequency of at least a fortnight and adopt the method given below for the disposal of various categories.
5.1.4 Dispose the material/product of potent drugs after analysis as per the SOP, Handling of potent drugs.
5.1.5 Transfer samples of excipients into a container, which shall be sent to ETP for further disposal.
5.1.6 Send the empty container to scrap yard for further disposal.
5.1.7 Packaging Material (Labels, Foils, Plastic, Glass, Metals, Cartons, leaflets, Shippers, Shipper pads, Gap fillers, thermocol, cotton, etc.). After analysis of the paper based printed packaging material render the samples unusable by cutting or shredding them.
5.1.8 Cut all plastic waste including polythene bags, LDPE, HDPE containers and other plastic vials, etc., to render them unusable. Collect and send to scrap yard for disposal.
5.1.9 Collect the waste generated in a container marked as ‘Container for Paper Waste’ and sent to the scrap yard for further disposal.
5.1.10 Transfer the left-over packaging materials of glass vials and prefilled syringe barrels in to container labeled as “broken glassware bin” and send the glass waste to crushing.
5.1.11 Crush Metal containers / samples/Aluminium foils and Aluminium seals and collect in a container marked as “Container for Metal Waste”. Render foil samples unusable by shredding /cutting/crushing them send to scrap yard for further disposal.
5.1.12 Rubber stopper shall be disposed after cutting/shredding the rubber stoppers.
5.1.13 For the disposal of any other packaging material which are not mentioned in this SOP, the same shall be sent to scrap yard for disposal, after rendering it unusable.
6.0 ABBREVIATION:
SOP: Standard Operating Procedure
etc.,: Etcetera
ex. : Example
ETP: Effluent Treatment Plant
LDPE: Low Density Poly Ethylene
HDPE: High Density Poly Ethylene
7.0 REFERENCES::
SOP for Handling of potent drugs
8.0 LIST OF ANNEXURES:
Nil
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