Standard Operating Procedure of Sampling Of Raw Material In Pharmaceuticals SOP is describe in this post.
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1.0 OBJECTIVE:
To
describe the procedure for sampling of raw material.
2.0 SCOPE:
This
SOP is applicable for the procedure for sampling of raw material.
3.0 RESPONSIBILITY:
3.1
Officer/Executive-Quality
Control.
4.0 ACCOUNTABILITY:
4.1
Manager-Quality
Control.
4.2
Head of the
Department.
5.0 PROCEDURE:
5.1
Select the raw
material to be sampled from under test list generate sample checklist.
5.2
Quality Control
Executive informs the Q.C Chemist to sample the material from the calculated
number of containers by following formula for each receiving report.
5.2.1
Each container of
the batch should be sampled for active material.
5.2.2
Container to be
sampled for excipients material = √n+1.
Where,
n=
Number of containers received.
5.2.3
If number of
containers is 3 or less than 3 (for excipients material), draw sample from each
container.
5.3
Select number of
containers to be sampled for excipients as per sampling plan as per given in
Annexure-1.
5.4
Prepare the labels
for containers to be sampled and sample bag/ container.
5.5
Prepare sampled
label for containers as follows “Sampled Label” on containers packs which are
selected for sampling shall be identified as N/1/n, N/2/n,....N/S/n.
Where,
N=
total number of packs/ containers.
S=
serial number of container selected for sampling.
n=
total number of containers taken for sampling.
5.6
Prepare labels for
pool sample and control sample with name of the material and batch no. refer
Annexure-2 for specimen samples checklist.
5.7
Arrange to bring
containers/ packs near the sampling booth. Ensure the containers are cleaned
externally before taking them inside the sampling booth.
5.8
Check the labeling
and physical condition of the container/ packs.
5.9
Ensure each pack
bear the vender/ manufacturer’s label indicating material name, batch no., mfg.
date, expiry date/ retest date and manufacturer’s name & address storage
condition and other precautions/ details if any.
5.10
Ensure that each
container/ pack is affixed with “UNDER TEST”. Verify & reconcile number of
containers and the total no. received as shown in the under test label.
5.11
Check the packing
condition of the containers/ packs for any damage. In case of any discrepancy,
inform Q.A Manager and warehouse Manager.
5.12
Physically damaged
container shall not be considered for sampling and will be rejected at the time
of approval/ rejection of the material.
5.13
All raw materials
after sampling shall be kept back to their designated place as per their
storage condition.
5.14
Sampling shall be done
specially from the damaged container if found ok including other randomly
selected pack or container as per sampling plan.
5.15
Before entering in
the sampling booth carry all uniform provided in the sampling area.
5.16
Check the sampling
booth cleanliness and the status label. Ensure sampling area and sampling booth
should be clean and free from remaining previous raw material.
5.17
Switch ‘ON’ the
laminar flow unit of the sampling booth and get it stabilized for 15 minutes.
5.18
Record the
temperature and relative humidity of the sampling booth in the logbook and it
should be in the respective range.
5.19
Before the
sampling activity affix label indication “UNDER SAMPLING” on the display
outside sampling room.
5.20
Bring the
containers/ packs in the sampling booth at a time open them carefully after
breaking seal/stretching.
5.21
Material of only
one batch no. shall be sampled at a time.
5.22
Open the primary
pack of the sealed container and proceed for sampling as per procedure.
5.23
Use dedicated
sampling aids for the sampling of the active ingredients.
5.24
Observe visually
appearance of the material for any abnormalities like discoloration, lumps,
non-characteristic odor and presence of foreign material.
5.25
Withdraw
approximately equal quantities from the all marked containers/ packs to make
the total withdraw quantity equivalent to the quantity specified for sample.
5.26
Master copy as
well as distribution copies of sample quantity will be live document and shall
be maintained manually, if any new product will incorporate with approval of
quality assurance.
5.27
The following
clean sampling equipment shall be used to sample different type of raw
material.
|
Long
glass tube |
For
liquid sampling from drum. |
|
Glass
pipette with rubber treat |
For
liquid sampling from bottle. |
|
S.S
Spatula |
For
sampling of material from small solid containers. |
|
S.S
Sampling knife/ Spoons |
For
sampling of solid raw materials from bags/ drums. |
5.28
Number of pooled
sample taken for analysis depends upon the number of containers to be sampled
(refer annexure-1).
5.29
If the number of
pooled sample of a particular material exceeds more than one, then assay of the
individual test sample has to be performed.
5.30
After sampling is
over tie the innermost bag with cable tie and close container/ pack properly.
Affix sampled labels (duly signed) on the container and send back the container
to the respective storage condition.
5.31
Check the glass
material used during sampling is free from any chipping before and after
sampling of each container.
5.32
After sampling is
over take out the dress given for sampling area and put them in the garment bin
and remove the ‘UNDER SAMPLING’ label from area.
5.33
Cleaning
Procedure of Sampling Aids:
5.33.1 On
the completion of sampling of each material ensure that the used aids are
transferred in a polythene bag to avoid cross contamination.
5.33.2 The
used sampling aids shall be washed with potable water using scrubber/ brush and
finally rinse with purified water, wipe the sampling aids using lint free
cloths.
5.33.3 Stretch
wrap the sampling aids place them in the oven, switch on the oven and let the
sampling tools dry.
5.33.4 Take
out all the sampling aids (dried) and wrap them in polyethylene bag and keep
them in the racks provided in the room.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
Annexure 1: Sampling
plan for in-active material.
Annexure 2:
Label Specimen.
Annexure: 1
Sampling
plan for in-active material
|
No. of containers in a batch |
No. of containers to be sampled |
No. of pooled samples to be
prepared for analysis |
|
1-3 |
All
containers |
1 |
|
4-8 |
3 |
1 |
|
9-15 |
4 |
1 |
|
16-24 |
5 |
1 |
|
25-35 |
6 |
1 |
|
36-48 |
7 |
1 |
|
49-63 |
8 |
1 |
|
64-80 |
9 |
1 |
|
81-99 |
10 |
2 |
|
100-120 |
11 |
2 |
|
121-143 |
12 |
2 |
|
144-168 |
13 |
2 |
|
169-195 |
14 |
2 |
|
196
& above |
15 |
2 |
Annexure:
2
Label
Specimen
|
SAMPLED |
|
|
Item name: |
|
|
Batch no.: |
|
|
Container no.: |
-------------of------------- |
|
Date of sampling: |
|
|
Sampled by & date: |
|
|
SAMPLE FOR ANALYSIS |
|
|
Product name: |
|
|
Batch no.: |
|
|
Batch size: |
|
|
Mfg. date: |
|
|
Exp. Date: |
|
|
Sample qty.: |
|
|
Sampled by & date: |
|
|
REJECTED |
|
|
Material name: |
|
|
Material code: |
|
|
Container no.: |
-------------of------------- |
|
Batch no.: |
|
|
Qty. of material: |
|
|
MRN No.: |
|
|
A.R. No.: |
|
|
Vender: |
|
|
Rejected by & date: |
|
|
APPROVED |
|
|
Name: |
|
|
Batch
no.: |
|
|
Item
code: |
|
|
Total
qty.: |
|
|
Number
of containers: |
|
|
MRN
No.: |
|
|
Retest
on: |
|
|
LOD/
Water content: |
|
|
Assay
(ODB/OAB) |
|
|
Analysts: |
|
|
Sign/
date: |
|