1.0 Purpose
1.1 To lay down a procedure for sampling of
intermediate (blend /core/coated/ capsule/ liquid), Bulk and finished product
(packing) during manufacturing operations.
2.0 Scope
2.1 This SOP shall be applicable to the IPQA
in Quality Assurance Department of NAME Pharmaceuticals Ltd.
3.0 Responsibility
3.1 In process Quality Assurance Officer shall be responsible to follow the procedure mentioned in this SOP
3.2 Head of Quality Assurance shall be
accountable for compliance of this SOP
4.0 Abbreviations and Definitions
4.1 None
5.0 Materials and Equipment
5.1 Fresh latex gloves
5.2 Spatula
5.2 Sampling rod /thief
5.3 Self-sealing polybag
5.4 Glass
beaker / bottle
6.0 Precaution / Health and Safety Considerations
6.1
Wear fresh latex gloves, before
sampling.
7.0 Procedure
7.1 Preparation:
7.1.1 On completion of intermediate / finished
product stage, check that the BMR/BPR is completed and signed up to that stage
and all the manufacturing steps are followed and documented, including stage
wise yields.
7.1.2 Production operator/ staff are affix the “INTERMEDIATE
/ BULK / FINISHED PRODUCT” QUARANTINE label (Annexure-I) on the container to be
used for sampling before keeping in “Intermediate Store “.
7.1.3 Production Officer will inform the
Quality Assurance Department through “REQUEST FOR SAMPLING” (Annexure-III).
7.1.4
Ensure the availability of clean spatula, self-sealing poly bags, label and
sampling rod.
7.1.5 Ensure that all the containers have
affixed labels with correct product and batch details.
7.2 Sampling of Final Blend, Core /Coated Tablets and capsules and Liquid
7.2.1 Sampling of Final Blend
7.2.1.1 Open the Container of the final blend
and take equal quantity of samples from different locations from different IPCs
using a cleaned Sampling rod (Total quantity of sample should approximately be
near to the quantity mentioned in Table No-1)
7.2.1.2
Collect the sample in self-sealing poly bags. Put the polybag into another
self-sealing polybag bearing label of complete pool sample details.
7.2.1.3
Ensure proper closing of the container after the sampling operation.
7.2.1.4
Submit the sample along with the “REQUEST FOR SAMPLING” and REQUEST FOR TEST) (Annexure-III)
form and make an entry in the in-process sample register at QC.
7.2.1.5
Affix “To be cleaned” label on spatula /sampling rod and send it for washing.
7.2.2 Sampling of Core /Coated
Tablets and capsules
7.2.2.1
Collect core / coated tablets from containers in such a manner that it must
cover that start, middle and end of the batch. If the batch is lot wise then
cover the lots and composite it in a self-sealing polybag.
7.2.2.2
Open the polybag of the containers of the core / coated tablets and take out
equal quantity of samples from different locations from different containers
(Total quantity of sample should approximately be near to the quantity
mentioned in Table No-1)
7.2.2.3
Collect the sample in self-sealing poly bags. Put the polybag into another
self-sealing polybag having the label with complete pool sample details.
7.2.2.3
Ensure proper closing of the container after the sampling operation.
7.2.2.4
Submit the sample along with “REQUEST FOR SAMPLING” and REQUEST FOR TEST) (Annexure-III)
form and make an entry in the in-process sample register at QC.
7.2.3 Sampling of Liquid
7.2.3.1
Mix the bulk for 5 minutes.
7.2.3.2
Take the sample from the filling area.
7.2.3.3
Submit the sample along with the “REQUEST FOR SAMPLING” and REQUEST FOR TEST) (Annexure-III)
and make an entry in the in-process sample register at QC.
|
TABLE-1 |
|
|
Dosage
Form |
Quantity
(Approximately) |
|
Final
(Blend) |
20 g |
|
Core
Tablets |
60
tablets |
|
Coated
Tablets |
60
tablets |
|
Capsules |
60
capsules |
|
Liquid |
200
ml |
7.3 Sampling of Finished
Products:
7.3.1 Withdraw an equal quantity of samples
from the packing line / master carton it will represent start, middle and end of the batch.
7.3.2
The sample quantity shall be equivalent to the quantity mentioned in Table
No. 2
7.3.3 Submit the sample along with the “REQUEST FOR SAMPLING” and REQUEST FOR TEST) (Annexure-III) and make an entry in the finished product register at QC.
|
TABLE-2 |
|
|
Dosage
Form |
Quantity
(Approximately) |
|
Tablets |
100
tablets |
|
Capsules |
100
capsules |
|
Liquid |
200
ml |
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 Annexure-I : “INTERMEDIATE / BULK / FINISHED PRODUCT” QUARANTINE label
9.2 Annexure-II : “INTERMEDIATE / BULK PRODUCT” RELEASE” label
9.3 Annexure-III : “REQUEST FOR SAMPLING”
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
- |
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|
|
|
|
11.1 Training is required for IPQA Officers, Production Officer and QC Officer trained by Head of Quality Assurance.
Annexure-I
“INTERMEDIATE / BULK / FINISHED PRODUCT” QUARANTINE label
|
NAME of
Company Address |
|
INTETMEDIATE / BULK /
FINISHED PRODUCT |
|
Process Stage :
______________________________________________ Product Name :
______________________________________________ Batch No :
_________________ Batch Size :
_________________ Mfg Date :
______________________________________________ Container No/ Drum No : ________________ of
___________________ Gross wt. :
__________________ Net wt. / Qty: _________________ Tare Weight :
______________________________________________ Storage Condition : Temp.: _________________ RH% : _________________ |
|
Done By/ Date : |
|
Checked By/ Date : |
|
QUARANTINE From No : Effective Date |
|
Logo |
NAME of Company. Address |
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QA RELEASED
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Product
Name |
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Batch No. |
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Batch
Size |
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Mfg. Date |
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Exp. Date |
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Lab Ref.
No. |
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Container No. |
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Released
for - |
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q Compression |
q Coating |
q Encapsulation |
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q Filling and Sealing |
q Blistering |
q Packaging |
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Tested
/ Checked By : |
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Approved By: |
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Sr. / QA
Officer |
Head
of QA |
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Ref. ………… |
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