1.0
Objective:
The objective of this standard Operating Procedure is
to lay down the procedure for
Handling and DESPOSAL of Retain
Samples.
2.0
Scope:
This SOP covers operating
procedure for handling and desposal of retain sample
3.0
Responsibility:
Retain sample-handling personnel
Responsible for collection, storage and
disposal of sample.
QA Officer/QAM: Review the records and governing the document.
4.0
Procedure:
4.1
Collection and
Receipt:
4.1.1
Sample of each booking Number shall be collected from the
sample receiving area by who is handling retain sample.
4.1.2
After collected the sample, enter all the required details of
sample in retain sample register. Segregate all the sample by product wise i.e.
Raw material, finished product (Tablet, Capsule, Syrup etc.) water and waste
water, soil sample and solid waste.
4.1.3
Personnel who receiving the sample will check the appearance
of sample, booking number and integrity of packing.
4.1.4
Keep the sample in corrugated box by month wise.
4.1.5
Store the samples at 25°C ± 1°C for 3 months from the
date of receipt.
4.1.6
Retain sample shall be checked if complaint from Sponsor.
4.2
Destruction:
4.2.1 The retain samples shall be destroyed after 3
months from the date of receipt.
4.2.2
Destruction of retain sample shall be recorded in the retain
sample register.
Strip/Blister of tablet or capsule shall be defoiled and shall be
put in disposal container containing water. Foil, Carton shall be cut into
pieces then put into the dustbin. Bottle shall be empty in waste disposal
container. Label of the same shall be cut into pieces and then put into dustbin
and destroy the bottle. Raw material destroys in waste disposal container
containing water. Water sample destroy
directly in drainage and waste water, soil sample & solid waste sample
destroy in hazardous waste container.
4.2.4 After destroy the material container shall be
send to effluent treatment plant
at ETP PLANT
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