Retention Time of Product/Raw Material/other records SOP
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1.0
PURPOSE:
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1.1.
To
ensure appropriate retention time of Product/Raw Material/other records in
________Pharmaceuticals.
2.1. It is applied to QC
Retained Samples of raw materials, packing material and finished products, also
on BMRs and general records
3.1. Q.A Manager
3.2. Q.C Manager
3.3. Production Manager
3.4. Inventory Control Manager
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4.0 PROCEDURE:
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Sr. No.
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Materials
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Retention Time
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Remarks
(if any)
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1.1.
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Retained Sample of Finished Goods
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1 year after expiry date
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1.2.
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Raw Materials Samples
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1 year after expiry date
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1.3.
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Packing Materials Samples
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3 years maximum
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Retention time started from date of sampling
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1.4.
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In-process Samples of products
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1 year after expiry date of product
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1.5.
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Batch History Records
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1 year after expiry date
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1.6.
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QC/QA/Production files and Records
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5 years maximum
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Retention time started from the date of last entry made in
log/record
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1.7.
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General Records
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10 years maximum
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Retention time started from the date of completion of
respective record
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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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Destruction Note of Retained Sample/
Batch History
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FORMAL KPIs
(Key Performance Indicators)
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Verification
of the product/records as and when required
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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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Product/Records
disposed off before completion of retention time
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There will be no evidence/record in
place (if needed in future)
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Before
destruction make a rough list of the materials to be disposed off, and verify
that all of them have completed their retention time
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QA Officer/QA Manager
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