Retest of Raw Materials SOP
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1.0
PURPOSE:
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1.1.
To
establish a procedure to ensure Quality/Specifications of the Materials.
2.1. This procedure applies to
all starting materials (API & Excipients) which are not used/consumed
before the re-test due date.
3.1. Inventory Control Manager
3.2. Store Pharmacist
3.3. Quality Control Manager
3.4. Quality Assurance Manager
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4.0 PROCEDURE:
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4.1. Store
Person checks the materials (API) for expiry date.
4.2. Remove
the materials (for which Re-test date is due), from released area and shift it
to Quarantine at least 15 days before due retest date.
4.3. Label
the material as “QUARANTINE”.
4.4. Intimate
QA for sampling of materials through sampling intimation
4.5. Material
sampling will be done as per SOP-07-003.
4.6. Affix
“SAMPLED” label.
4.7. When
material is released by QC, Re-locate the material to respective released area
and label it as “RELEASED”.
4.8. If
material is rejected then shift it to Reject Area and label it as “REJECTED”
and dispose it as per relevant SOP.
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5.0
NOTE:
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5. NOTE: The
material (API) is only to retest when retest date is mentioned on CoA of the
material (API). If only the expiry date is mentioned then material will be
Rejected on the basis of expiry date, retesting will not be done for it.
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EVIDENCES OF RECORDS & REFERENCES
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QC Reports.
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FORMAL KPIs (Key Performance Indicators)
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Proper labeling of the materials in Raw
Materials Store
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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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Materials are not being checked before expiry
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Dispensing of expired materials for batch
manufacturing
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Ensure retesting of materials for which retest is required
as per COA of the material.
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Store Pharmacist
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