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 |
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.