Finished Product Sampling SOP
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1.0
PURPOSE:
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1.1.
To
establish a procedure for sampling of finished goods.
2.1. It is applicable to all
finished products in all sections of Production Department.
3.1. Quality Assurance Manager
3.2. Quality Assurance Officer
3.3. Production Pharmacist
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4.0 PROCEDURE:
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4.1. Q.A
Officer after the final packaging of the product receives the request for
analysis from Production Department.
4.2. Q.A
officer collects the random sample from different shipper/cartons of Finished
Product, number of total packs to be collected are specified in F-07-007,
(Minimum Quantity of Finished packs for Retained Sample and Stability Studies),
4.3. Production
Pharmacist enters the no. of packs taken by Q.A officer in log book of
“Quantity of Retained Sample” (RSLB-05-005) and Q.A Officer will sign it after
receiving the sample.
4.4. Q.A
Officer then hand over the analysis request to Q.C Analyst for analysis of
finished goods.
4.5. 1
finish pack (if required more than 1) is used for test/analysis at finished
product stage, and the remaining packs are retained in Retained Sample Room in
QC Lab.
4.6. Collected
sample is recorded in QA register of Retained sample by QA Officer with:
4.6.1. Product
Name
4.6.2. Mfg.
Date
4.6.3. Exp.
Date
4.6.4. No. of
packs taken
4.6.5. Date
of sampling
4.6.6. Signature
4.7. Q.C
Manager will issue the finished product test report after the sample has been
analyzed as per specifications.
4.8. Retain
sample packs are stored in Retained Sample Room; maintained at temperature NMT
30oC ±2oC and NMT 60% ± 5% Relative Humidity.
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5.0
REVIEW FREQUENCY:
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SOP will be reviewed at least annually.
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EVIDENCES OF
RECORDS & REFERENCES
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Retained Sample
Register (QA Register)
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FORMAL KPIs
(Key Performance Indicators)
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Entry of the
retain sample in register as soon as the sample has been collected
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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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Collected
sample is less than the specified sample size
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Not enough for
future examination/ testing will be compromised
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Always make sure to collect the exact sample as
specified in F-07-007
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QA Officer/
QA Attendant
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Retaining of
Sample is not recorded in register
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No evidence for
sample will be available
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Entry in the register must be made as soon as
the sample is retained in the room
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Temp/RH not
maintained in retained sample room
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Product quality
will be effected
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Maintain required/proper temperature and
humidity and record it on daily basis
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