Sampling of Product at Intermediate Stages

Objective
To lay down a procedure for sampling of product at different intermediate stages of all production areas.

2.0 Scope
This Standard Operating Procedure is applicable for in process 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.
LAF : Laminar Air Flow
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 annexure-1and

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 QA Officer / Executive shall verify the filled BPCR up to the manufacturing process

and if found satisfactory then only go for sampling. If any discrepancy found in filled

BPCR then same shall be rectified by production before sampling.
5.4 QA Officer / Executive shall use the clean, dry sampling devices such as spatula, spoons,

sampling rod, self sealing polybags, vials and glass bottles for sampling as per nature of product shown in annexure- 2.
5.5 QA Officer / Executive shall prepare the in process label as per annexure -3 and affix on the sampling container or bags.
5.6 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.
5.7 QA Officer / Executive shall withdraw the sample as per quantity mentioned in annexure-4.
5.8 After collection of sample, QA Officer / Executive shall enter the sample details in

“In process sample analysis record” as per annexure-5 and give the QA reference no. to the sample.
5.9 After completion of documentation QA Officer / Executive shall send the sample

with intimation to QC for analysis.
5.10 QC Officer / Executive shall receive the sample and sign in the “In process sample

analysis record” as a token of receipt of sample.
5.11 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.
5.12 In-Process sampling procedure for tablet / capsule
5.12.1 QA Officer / Executive shall collect the required quantity of sample from bin

with the help of sampling rod and make a composite sample.
5.12.2 Incase of validation batch, QA Officer / Executive shall collect the sample

as per product specific validation protocol.
5.12.3 After sampling, close the lid of bin and affix the in process sample label on container / bags.
5.12.4 After sampling QA Officer / Executive shall enter the sampling details in BPCR
5.13 In-process sampling procedure for liquid bulk
5.13.1 Stir the bulk for at least 05 minutes before taking the sample to make the bulk homogenous.
5.13.2 QA Officer / Executive shall collect the sample of bulk from manufacturing tank with

the help of liquid sampler and make a composite sample.
5.13.3 In case of validation batch, sample shall be collected as per product specific validation protocol.
5.13.4 After sampling, close the lid of tank and affix the in process sample label on the sampling bottle.
5.13.5 After sampling QA Officer / Executive shall enter the sampling details in BPCR
5.13.6 In case of validation batch, collect the sample as per specific product validation protocol.
5.13.7 After sampling, close the lid of blender and affix the “in process sample label” on the vials.
5.13.8 After sampling QA Officer / Executive shall enter the sampling details in BPCR
5.14 In-process sampling procedure for liquid bulk
5.14.1 Stir the bulk for at least 05 minutes before taking the sample to make the bulk homogenous.
5.14.2 QA Officer / Executive shall collect the sample of bulk from manufacturing tank with the help

of liquid sampler and make a composite sample.
5.14.3 In case of validation batch, sample shall be collected as per product specific validation protocol.
5.14.4 After sampling, close the lid of tank and affix the in process sample label on the sampling bottle.
5.14.5 After sampling QA Officer / Executive shall enter the sampling details in BPCR
5.14.6 In case of validation batch, collect the sample as per specific product validation protocol.
5.14.7 After sampling, close the lid of blender and affix the “in process sample label” on the vials.
5.14.8 After sampling QA Officer / Executive shall enter the sampling details in BPCR
6.0 Forms and Records
6.1 Analysis request cum report for in process / Finished product – Annexure- 1
6.2 Types of containers used for sampling – Annexure- 2
6.3 In process sample label – Annexure- 3
6.4 In process sample quantity – Annexure- 4
6.5 In process sample log record – Annexure- 5
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Production
8.0 History