Sampling of finished product SOP
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1.0
PURPOSE:
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1.1
To lay
down a procedure for sampling of Finished Product.
2.1 This SOP shall be applicable to Quality
Control Dept.
3.1 Quality
Assurance Supervisor.
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4.0 ACCOUNTABILITY:
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4.1 Sr.
Manager Quality Assurance.
4.2 Head
of the Department.
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5.0 PROCEDURE:
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5.1 For liquids orals:
5.1.1 The packing
department shall inform the start of packing operations of the batch to QA
person.
5.1.2 The QA person shall
collect the sample from the packing line.
5.1.3 The quantity of the
sample shall be such as to enable complete analysis of product at least twice.
5.1.4 Sampling of products
for analysis, from the packing section shall be as per master document.
5.1.5 Collect the sample
on initial, middle and final stage of packing operation.
5.2 For tablets/
capsules:
5.2.1 Final sample for the
finished Product shall be collected on initial, middle and final stage of
blistering/ stripping/ packing by QA person.
5.2.2 Sampling of products
for analysis, from the packing section shall be as per master document.
5.2.3 Finished product
sampling should be done online as required in the product specification,
preferably after approximately 50% of bulk is packed.
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Abbreviation
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Expanded Form
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S
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Standard operating procedure
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&
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And
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%
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percentage
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06
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Inventory Control
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