The document outlines the standard operating procedure for sampling, testing, and releasing or rejecting finished products. It describes the steps taken by quality control personnel, including receiving sampling requests, collecting and labeling samples, distributing samples for analysis, testing samples according to procedures, reviewing results, and releasing or rejecting batches based on specifications. Key steps involve sampling from containers, analyzing samples in the chemical and instrument labs, approving results, and recording the final status of batches.

1. SAMPLING, TESTING AND
RELEASE / REJECTION OF
FINISHED PRODUCT
Presented by
Malangsha
shkrahul42@gmail.com
1
SAMPLING, TESTING AND
RELEASE / REJECTION OF
FINISHED PRODUCT
Presented by
Malangsha
shkrahul42@gmail.com

2. Quality Control Department shall receive "Sampling
request" from the production department, as intimation for
product sampling.
Executive – QC shall enter the details in the finished product
inward register as per the sampling request and assigns an
Analytical Reference Number (A.R.No.) as per SOP.
Executive-QC shall prepare sample labels and approach
production department along with Self sealed polyethylene bags,
sampling devices (SS Spoons/Scoops/Spatulas) and sampling
check list, to proceed for sampling.
 Sampling devices shall be dedicated and product specific.
Quality Control Department shall receive "Sampling
request" from the production department, as intimation for
product sampling.
Executive – QC shall enter the details in the finished product
inward register as per the sampling request and assigns an
Analytical Reference Number (A.R.No.) as per SOP.
Executive-QC shall prepare sample labels and approach
production department along with Self sealed polyethylene bags,
sampling devices (SS Spoons/Scoops/Spatulas) and sampling
check list, to proceed for sampling.
 Sampling devices shall be dedicated and product specific.
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Quality Control Department shall receive "Sampling
request" from the production department, as intimation for
product sampling.
Executive – QC shall enter the details in the finished product
inward register as per the sampling request and assigns an
Analytical Reference Number (A.R.No.) as per SOP.
Executive-QC shall prepare sample labels and approach
production department along with Self sealed polyethylene bags,
sampling devices (SS Spoons/Scoops/Spatulas) and sampling
check list, to proceed for sampling.
 Sampling devices shall be dedicated and product specific.
Quality Control Department shall receive "Sampling
request" from the production department, as intimation for
product sampling.
Executive – QC shall enter the details in the finished product
inward register as per the sampling request and assigns an
Analytical Reference Number (A.R.No.) as per SOP.
Executive-QC shall prepare sample labels and approach
production department along with Self sealed polyethylene bags,
sampling devices (SS Spoons/Scoops/Spatulas) and sampling
check list, to proceed for sampling.
 Sampling devices shall be dedicated and product specific.

3. Executive-QC along with QA representative shall check the
under test labels on the containers with respect to sampling
request.
 In case of discrepancy, the same shall be informed to
production incharge to resolve the issue.
 Executive-QC shall wear suitable safety devices and open all the
containers.
In the case of hygroscopic materials container wise shall be
opened, sampled and closed immediately under nitrogen
atmosphere.
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Executive-QC along with QA representative shall check the
under test labels on the containers with respect to sampling
request.
 In case of discrepancy, the same shall be informed to
production incharge to resolve the issue.
 Executive-QC shall wear suitable safety devices and open all the
containers.
In the case of hygroscopic materials container wise shall be
opened, sampled and closed immediately under nitrogen
atmosphere.

4. Executive-QC shall check the physical appearance of the
material and mix the contents thoroughly within the container
by sampling devices.
If the physical appearance of the material is same in all
the containers, then all samples shall be collected into a self
sealed polythene bag.
 In case of discrepancy of physical appearance, the same
shall be in formed to Head- QC and QA.
All observations of sampling shall be recorded in "Finished
Product Sampling check list" .
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Executive-QC shall check the physical appearance of the
material and mix the contents thoroughly within the container
by sampling devices.
If the physical appearance of the material is same in all
the containers, then all samples shall be collected into a self
sealed polythene bag.
 In case of discrepancy of physical appearance, the same
shall be in formed to Head- QC and QA.
All observations of sampling shall be recorded in "Finished
Product Sampling check list" .

5. Sampling shall be done from all the containers in such away that
the total quantity shall be sufficient for three complete analyses
(approximately 170 g).
 Quantity justification for Finished product:
•60 g for chemical & instrumental analysis
(i.e., 55g for chemical and 5gm for instrumental analysis).
• 60 g for Retention sample (30 g x 2).
• 5Og for Microbiology (if required).
In case of additional tests /market samples, additional
quantity shall be sampled and the same shall be recorded.
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Sampling shall be done from all the containers in such away that
the total quantity shall be sufficient for three complete analyses
(approximately 170 g).
 Quantity justification for Finished product:
•60 g for chemical & instrumental analysis
(i.e., 55g for chemical and 5gm for instrumental analysis).
• 60 g for Retention sample (30 g x 2).
• 5Og for Microbiology (if required).
In case of additional tests /market samples, additional
quantity shall be sampled and the same shall be recorded.

6. Post sampling, batch containers shall be sealed immediately
and seal numbers shall be recorded in BPCR by the Assistant-
Production and Executive-QC shall affix "Sampled" labels on
the containers adjacent to under test Labels.
 Sampling Executive shall check the integrity of the sampling
devices after sampling.
 Collected composite samples shall be brought to QC and
distributed for chemical/instrument lab/Retention sample and
microbiology analysis.
 Retention samples shall be packed as per market simulating
conditions and preserved immediately.
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Post sampling, batch containers shall be sealed immediately
and seal numbers shall be recorded in BPCR by the Assistant-
Production and Executive-QC shall affix "Sampled" labels on
the containers adjacent to under test Labels.
 Sampling Executive shall check the integrity of the sampling
devices after sampling.
 Collected composite samples shall be brought to QC and
distributed for chemical/instrument lab/Retention sample and
microbiology analysis.
 Retention samples shall be packed as per market simulating
conditions and preserved immediately.

7. The QC Analyst shall test the samples as per respective standard
test procedures.
All the raw data generated during analysis shall be recorded in
the respective protocol.
Calculations / observations /chromatograms and reports
related to analytical data shall be attached with the analytical
protocol.
 Section head shall review the raw data thoroughly and upon
execution forwards to Head-QC/Deputy for approval.
 Head-QC/Deputy shall verify the data randomly, approves
the document and forward the protocol to QA.
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The QC Analyst shall test the samples as per respective standard
test procedures.
All the raw data generated during analysis shall be recorded in
the respective protocol.
Calculations / observations /chromatograms and reports
related to analytical data shall be attached with the analytical
protocol.
 Section head shall review the raw data thoroughly and upon
execution forwards to Head-QC/Deputy for approval.
 Head-QC/Deputy shall verify the data randomly, approves
the document and forward the protocol to QA.

8.  QA shall further review and forward the batch release
certificate to QC.
Finally QC shall prepare the "Release for Further Processing"
labels and affix on under test labels of the containers.
If the case of failure in quality parameters, OOS (Out of
specification) shall be initiated and investigation shall be
carried out.
Based on the investigation recommendation, status of the
material shall be concluded.
 The final status of the material shall be recorded in
concerned inward registers along with date of release.
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 QA shall further review and forward the batch release
certificate to QC.
Finally QC shall prepare the "Release for Further Processing"
labels and affix on under test labels of the containers.
If the case of failure in quality parameters, OOS (Out of
specification) shall be initiated and investigation shall be
carried out.
Based on the investigation recommendation, status of the
material shall be concluded.
 The final status of the material shall be recorded in
concerned inward registers along with date of release.

9. If the investigation concludes with rejection, "Rejected labels"
shall be affixed on the batch containers.
Additional tests (as per customer/Market/Regulatory
requirements) shall be performed and raw data shall be recorded
in the additional raw data sheet.
Such additional test results shall be captured along with batch
certificate of analysis.
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If the investigation concludes with rejection, "Rejected labels"
shall be affixed on the batch containers.
Additional tests (as per customer/Market/Regulatory
requirements) shall be performed and raw data shall be recorded
in the additional raw data sheet.
Such additional test results shall be captured along with batch
certificate of analysis.