STANDARD OPERATING PROCEDURE SAMPLING OF FINISHED PRODUCTS
STANDARD OPERATING PROCEDURE
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SUBJECT :
SAMPLING
OF FINISHED PRODUCTS
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DEPARTMENT : QA
SOP
NO. :
Page
No :
Effective
Date :
Next
Review :
Version
No :
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1.0 OBJECTIVE:
To
provide guidelines for sampling of finished product.
2.0 SCOPE:
To lay down a procedure for sampling of Finished
Products.
3.0 PROCEDURE:
3.1. G M (QA) will depute a Executive QA for sampling of the product.
When the packing of the product is being done, samples will be collected at
random intervals and pooled. Sufficient sample required for physical, chemical
and micro.
3.2.
On completion of Batch the Executive
QA/ Jr.Executive QA will sample the product.
3.3. Prescribed
procedure will be followed for testing of various products sample size for different
Products format is included in annexure-1 Sop No. 07/QA.
3.4 LIQUIDS/
SUSPENSIONS:
3.4.1
Samples are to be drawn at random
intervals during packing.
3.4.2 Using
suitable clean sampler draw sufficient quantity of samples in a clean, dry and labeled
container.
3.4.3 For
microbial test the sample will be collected separately.
3.5. TABLETS:
3.5.1
Draw the samples at random intervals
during packing.
3.5.2 Pool and
store the samples in a clean dry and labeled Container/carton or polythene bag.
3.6. OINTMENT,
CREAMS & LOTION:
3.6.1
Draw the samples at random intervals
during packing.
3.6.2
Pool all samples and store in clean dry
labeled polybags.
3.7. SAMPLE
SIZE:
3.7.1 Qty. of sample to be collected as per
following Annexure.
4.0 FREQENCY:
As and when the batch is completed / required.
5.0 RESPONSIBILITY: Executive QA.
6.0 REVIEW
GUIDE: --
7.0 ANNEXURE: 1. Sample Size for Different Products
8.0 SOPs
DISTRIBUTION:
This
SOP shall be distributed to following Departments:
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Name of the Department
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Master Copy
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Circulatory Copy
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QA/QC
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√
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√
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Production
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x
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√
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Warehouse
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x
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x
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General
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x
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x
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Maintenance
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x
|
x
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