Sampling Procedure | Swab Sample, Finished Product, Rinse Sample

Rahul Kashyap
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Purpose
The purpose of this SOP is to establish a procedure for Sampling of In-process, Finished product and Rinse and swab sample.
Procedure:
Executive/ Designee - QA shall prepare sampling plan of In-process sample quantity required during in-process and sampling plan of finished product
Executive/ Designee - QC review sampling plan for quantity required during in-process stage and finished product sample quantity.
Sampling plan shall be updated whenever there is any new product addition/ discontinuation or change in sample quantity.
Sampling plan shall be prepared product wise or any other sample requirement specific to the product e.g. outside lab testing sample, customer sample etc.
After preparation, Executive/ Designee - QA shall forward the sampling plan to QC for review and Head-QA for approval.
After approval of sampling plan of in process and finish product sample quantity, sampling plan shall be submitted to QA for control and distribution.
QA department shall distribute the in-process and finished product sampling plan to concern department.
Rinse sample:
After completion of the cleaning activity, Executive/ Designee-PRD shall raise intimation for rinse sampling & testing and forward to IPQA.
Sample intimation shall be prepared in duplicate copies. First copy shall be sent to QC along with samples and second copy shall be retained in the intimation book.
After receiving the intimation IPQA personnel shall initiate the process for rinse sample.
Visually check the product contact surface for cleanliness and previous product residue. Along with visual inspection equipment shall also be checked for presence of odor of previous batch. Neither any visible residue or any odor should be observed.
If visual and odor inspection complies, rinse sample shall be collected.
Take required quantity of purified water in clean SS container. Pour into cleaned equipment (product contact part of equipment) and rinse the equipment with purified water.
Collect the rinse water in a clean wide mouth container.
Take the 100 ml of the final rinse in the glass bottle from the above collected rinse sample and label the bottle and transfer to the QC laboratory.
Check the rinse sample visually for presence of any particle or turbidity. It should not be observed.
If rinse sample complies, IPQA Officer/ Designee shall forward the rinse sample along with test intimation slip to Quality Control for analysis.
Executive/ Designee - QC shall receive the rinse sample along with intimation, analyze the sample as per specification.
After analysis Executive/ Designee - QC shall fill the results in the rinse sample intimation slip and return the original copy to IPQA.
 If equipment fails in visual or odor inspection or any particle or turbidity observed in rinse sample or rinse sample fails in QC, it shall be re-cleaned and appropriate documentation shall be performed.
Swab sample:
Swab sample shall be collected during cleaning validation activity or any other study as required by QA.
Swab sample shall be collected for chemical analysis or microbial analysis or both.
Swab sample shall be collected in the media/ solvent in which the residue is supposed to be freely or highly soluble.
After completion of the cleaning activity, Executive/ Designee-PRD shall raise intimation for swab sampling & testing and forward to IPQA.
Sample intimation shall be prepared in Duplicate copies. First copy shall be sent to QC along with samples and second copy shall be retained in the intimation book.
After receiving the intimation IPQA personnel shall initiate the process for rinse sample.
Visually check the product contact surface for cleanliness and previous product residue. Along with visual inspection equipment shall also be checked for presence of odor of previous batch.
Neither any visible residue or any odor should be observed.
If visual and odor inspection complies, swab sample shall be collected.
Fill the swab tube with the sampling diluent/ media and dip the swab stick in the media.
Take the swab sample from 25cm2 (5cm x 5cm) surface of the equipment from the identified location.
Take the swab sample by firmly rubbing the swab stick in horizontal and vertical direction as depicted in the below figure
Swab Method for Sampling
Swab Method
During sampling precaution to be taken not to repeat the sampling from the same location with every streak.
After sampling put the swab media back in the swab tube.
Check the swab sample visually for presence of any particle or turbidity. It should not be observed.
If swab sample complies, IPQA Officer/ Designee shall forward the swab sample along with test intimation slip to Quality Control for analysis with appropriate labelling.
Executive/ Designee - QC shall receive the rinse sample along with intimation, analyze the sample as per specification.
After analysis Executive/ Designee - QC shall fill the results in the swab sample intimation slip and return the original copy to QA.
If equipment fails in visual or odor inspection or any particle or turbidity observed in   swab sample or swab sample fails in QC, it shall be re-cleaned and appropriate documentation shall be performed.
In-process sample:
The IPQA personnel shall ensure the following points before performing the sampling activity/ sending samples to QC at respective stage:
-BMR updated up to the stage at which the sampling is to be done.
After completion of the in-process stage, Executive/ Designee-PRD shall raise intimation for in-process stage as per In-process Sample Quantity and forward to IPQA.
Sample intimation shall be prepared in triplicate copies. First and second copy shall be sent to QC along with samples and third copy shall be retained in the intimation book. If intimation is raised through Company Designated Software, then Single Copy shall be sent to QC for Results incorporation.
IPQA Officer/ Designee shall perform sampling (approximate quantity) of in-process stage as per in process Sample quantity.
 Sampling shall be done by using cleaned SS Sampler from manufacturing vessel.
IPQA Officer/ Designee shall forward the sample along with test intimation slip to Quality Control for analysis after pouring it in glass bottle appropriately labelled as per SOP for status labelling
Executive/ Designee - QC shall receive the sample along with intimation for in-process stage, analyze the sample as per specification.
After analysis Executive/ Designee - QC shall fill the results in the sample intimation slip and return the original copy to IPQA.
Officer/ Designee - IPQA shall attach QC release intimation slip with concerned Batch record and as per the result received from QC, releases the batch for filling.
Finished product sampling/ Control sample/ Stability sample:
Finished product shall be sampled during the packing operation in progress by randomly collecting the sample during start at 20%, middle at 50% and at end 80% of packing operation.
After the finished product sampling, Executive/ Designee-PRD shall raise intimation for finished product sampling and forward to IPQA.
Sample intimation shall be prepared in duplicate copies. First copy shall be sent to QC along with samples and second copy shall be retained in the book.
IPQA Officer/ Designee shall forward the sample along with test intimation slip to Quality Control for analysis.
Executive/ Designee-QC shall receive the sample along with intimation for finish product stage, analyze the sample as per specification.
After analysis Executive/ Designee-QC shall fill the results in the sample intimation slip and attach the copy with raw data of the analysis performed and releases the COA.
New Product shall be introduced in sample list through addendum. sample list shall be updated on quarterly basis or as and when required. 

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