Raw
Material Sampling SOP
1.0
PURPOSE:
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1.1. To ensure a
procedure for sampling of Raw Materials to get a representative sample of whole
lot/batch for analysis.
2.0 SCOPE:
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2.1. This procedure
is applicable for sampling of all raw materials received at __Pharmaceuticals
3.0 RESPONSIBILITY:
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3.1. QA Manager
3.2. Inventory Control Manager
3.3. QA Officer
4.0 PRECAUTIONS:
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4.1. Run the sampling booth at least 30 minutes
before sampling
4.2. Clean and mop the area before sampling
4.3. Care should be taken to avoid
contamination and cross contamination during sampling
4.4. Always take sample of one material at one
time to avoid cross contamination
4.5. Always use Clean and dry sampling tool for
each sample to avoid contamination and cross contamination.
5.0 LIST OF SAMPLING TOOLS:
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5.1. Scoops
5.2. Sampling Rods
5.3. Pipette
5.4. Spatulas
5.5. Glass Beakers
5.6. Poly bags
6.0 PROCEDURE:
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6.1. QA Manager receives the sampling/testing
intimation (F-06-005) from the inventory control manager.
6.2. QA officer in the presence of Store Person
checks the container(s) that it has been placed properly in Quarantine and an
identification card “QUARANTINE” is pasted on each container, also make sure
that the information being provided in sampling request is correct or not,
according to the identification/information label on container and COA.
6.3. Material received must be from an approved
vendor, material will not be sampled if it is not from an approved vendor.
6.4. Material will be shifted from Quarantine
to Sampling Booth before sampling.
6.5. Check physical condition of the container
for any damage/loose seal or packing, etc.
6.6. QA Officer wears mask and gloves before
taking the sample.
6.7. Keeping in account the sensitivity of
material towards light and moisture, QA Officer takes the sample with a
sampling rod/pipette to ensure sampling from top, center and bottom of the
container.
6.8. Sample will be collected in:
6.8.1. A poly bag for solids
6.8.2. A glass beaker for liquids
6.9. For API, all containers will be sampled
and identify separately but potency will be of collective sample of same
lot/batch.
6.10. For excipients, the no. of samples is
determined from American Military Standard
MIL-STD 105E. The formula of √n + 1, where n=
number of containers. This
formula will be applicable where no. of
containers is more than 4. If no. of
containers is 4 or less than 4 then all
containers will be sampled.
6.11. Sample size is as follows:
6.11.1. For solid raw materials: NLT 2g
6.11.2. For liquid raw materials: NLT 100ml
6.11.3. For flavors (liquids): NLT 50ml
6.12. After sampling close each container tightly
in proper way and shift back to Quarantine with a “SAMPLED” sticker pasted on
it.
6.13. QA Officer will enter all the sampling
record in SLB-07-003.
6.14. Sample is then handed over to the QC analyst
for analysis
6.15. Sample is tested and then Quality Control
Manger will decide about the release or
rejection of the material with respect to
testing results.
6.16. After release material is labeled with
“RELEASED” slip (Green colored) and
shifted to release area of raw material
store.
6.17. If rejected then material is labeled with
`“REJECTED” slip (Red colored) and
shifted to rejected area of raw material
store.
5.0
QUALITY FORMS AND RECORD:
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N-A
EVIDENCES OF RECORDS
& REFERENCES
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Request for QC Analysis
Raw Material Sampling Log
Book (SLB-07-003)
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FORMAL KPIs (Key
Performance Indicators)
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No. of materials being
sampled
Sampling Time
Record maintenance in
Sampling log book
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GENERAL RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Sampling is not done under
LFH
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Contamination from outside/
cross contamination
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Make sure the running of LFH before sampling
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Inventory Control Manager/
QA officer
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Identification label of Quarantine/
SAMPLED not pasted
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Mixing of Sampled or
non-sampled containers
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Paste Quarantine Label after receiving the materials
and SAMPLED label after sampling
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Light/moisture sensitive
materials are not handled as prescribed
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Material may lose its efficacy/
Analytical testing will be effected
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Keep the prescribed method of sampling in account ,
in order to retain the material safety
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