sop for Sampling Procedure for Finished Product Samples

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sop for Sampling Procedure for Finished Product Samples

Objective
To lay down a procedure for sampling of finished products of all production areas.
2.0 Scope
This Standard Operating Procedure (SOP) is applicable for finished product sampling of tablet, capsule,

liquid, External to be followed at formulation plant of abc Pvt. Ltd.
3.0 Responsibility
3.1 Production Officer / Executive shall be responsible for giving intimation to QA after completion of manufacturing process.
3.2 Officer / Executive QA shall be responsible for sampling as per intimation received from production

and submission of samples to the quality control department.
3.3 Head / In charge, Quality Assurance or his/ her designee shall be responsible for compliance of SOP
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
Composite Sample : Sample collected from various identified locations within a lot or batch, or from

various phases of process and then pool the sample to represent the sample of whole batch or lot.
BPCR : Batch Production and Control Record.

5.0 Procedure
5.1 After completion of manufacturing process, production officer / executive shall fill

the “Analysis request cum report for in process / finished product” as per SOP No.

and intimate the QA Officer / Executive for sampling as per intimation.
5.2 “Analysis request cum report for in process / finished product” contains three copies of

intimation slip having the following details for distribution.
5.2.1 Pink color – BPCR Copy
5.2.2 Yellow color – QC Copy
5.2.3 White color – Production Copy
5.3 Before sampling QA Officer / Executive shall check and verify the manufacturing area, status

label of area, status label of product and container as per BPCR.
5.4 After collection of sample, QA Officer / Executive shall enter the sample details

in “Finished Sample Analysis Record” as per annexure-1 and give the QA reference no. to the sample.
5.5 QA Officer / Executive shall prepare the “Finished Sample label” as per annexure -2 and affix

on the sampling container or bags.
5.6 QA Officer / Executive shall withdraw the sample as per quantity mentioned in annexure-3
5.7 QA Officer / Executive shall verify the filled BPCR up to the manufacturing process and if

found satisfactory then only send the sample to QC. If any discrepancy found in filled BPCR

then same shall be rectified by production.
5.8 After completion of documentation QA Officer / Executive shall send the sample

with intimation to QC for analysis.
5.9 QC Officer / Executive shall receive the sample and sign in the “Finished sample analysis record”

as a token of receipt of sample.
5.10 After receiving result from QC, QA Officer / Executive shall attach the BPCR copy of slip into

the BPCR and allow the process to proceed further.
5.11 Sampling procedure for tablet / capsule
5.11.1 QA Officer / Executive shall collect the samples at different intervals of tablet compression / Capsule

filling and at the end of process, in case of coated tablets sampling shall be done from each lot and

after completion of the process a composite sample shall be made and shall send to QC in a double self sealing sample bags.
5.11.2 Incase of validation batch, QA Officer / Executive shall collect the sample as per product specific validation protocol.
5.11.3 After sampling, affix the finished sample label on container / bags.
5.11.4 After sampling QA Officer / Executive shall enter the sampling details in BPCR.
5.12 Finished sampling procedure for filled liquid bottles
5.12.1 QA Officer / Executive shall collect the filled bottles at different intervals of filling and sealing

and at the end of process, composite sample shall be made and send to QC with intimation.
5.12.2 In case of validation batch, sample shall be collected as per product specific validation protocol.
5.12.3 After sampling QA Officer / Executive shall enter the sampling details in BPCR
5.13 Finished sampling procedure for filled External
5.13.1 QA Officer / Executive shall collect the filled bottles at different intervals of filling and sealing and

at the end of process, composite sample shall be made and send to QC with intimation.
5.13.2 In case of validation batch, sample shall be collected as per product specific validation protocol.
5.13.3 After sampling QA Officer / Executive shall enter the sampling details in BPCR
6.0 Forms and Record
6.1 Finished Sample Log Record – Annexure- 1
6.2 Finished Sample label – Annexure- 2
6.3 Finished Sample Quantity – Annexure- 3
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Production
8.0 History