Phase 1
Receipt and Incoming Control
1Receive and verify against documentation
Incoming shipment verified against the purchase order and supplier shipping documentation before acceptance into the facility.
21 CFR 211.80
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2Inspect container integrity and transport conditions
Containers inspected for damage or tampering, and any temperature or condition monitoring devices reviewed for excursions during transport.
21 CFR 211.80
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3Assign a unique receipt identifier and quarantine status
Unique internal lot or receipt number assigned, with material immediately labeled with quarantine status pending sampling and testing.
21 CFR 211.82
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4Segregate into the quarantine area
Material physically moved into a defined quarantine area, separated from released material to prevent any possibility of premature use.
EU GMP Chapter 3
Phase 2
Quarantine, Sampling and Testing
5Sample per the approved sampling plan
Representative samples drawn according to a documented, statistically justified sampling plan appropriate to the material and its risk profile.
21 CFR 211.84
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6Perform incoming QC testing and identity verification
Identity testing performed at minimum on every container, with additional testing per the material specification and risk classification.
21 CFR 211.84
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7Review supplier certificate of analysis
Supplier CoA reviewed against in-house testing results, with any discrepancy investigated before the material proceeds toward release.
ICH Q7
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Does the material meet all acceptance criteria?
YES → Release for use
NO → Reject and initiate disposition
Phase 3
Release and Warehouse Storage
8Update status and relabel
Material status formally updated to released in the inventory system, with physical labeling updated to reflect the new status before relocation.
21 CFR 211.82
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9Store per condition requirements
Released material stored in the appropriate warehouse location meeting its required temperature, humidity, and segregation conditions.
21 CFR 211.80
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10Maintain rotation and reconcile inventory
First-in-first-out or first-expired-first-out rotation maintained, with periodic inventory reconciliation confirming system records match physical stock.
ICH Q7
Phase 4
Dispensing, Staging and Production Flow
11Dispense per batch record requirements
Materials weighed or measured in a controlled dispensing area per the specific batch record, with second-person verification of identity and quantity.
21 CFR 211.101
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12Stage for production with maintained traceability
Dispensed materials staged for the specific batch, clearly labeled and segregated from materials staged for any other concurrent batch.
EU GMP Chapter 5
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13Manage waste and return flow separately
Rejected material, waste, and returns routed through a distinct physical and documentary flow, never intersecting with the approved material path.
21 CFR 211.87
Material Status Labeling Requirements
Unambiguous Visual Status
Status distinguishable at a glance, commonly through color-coded labels or tags, so personnel can identify material status without reading detailed documentation.
EU GMP Chapter 5
System and Physical Status Match
Inventory system status and physical label status kept synchronized at all times, with any discrepancy investigated immediately upon discovery.
21 CFR 211.82
Full Traceability to Source
Every material lot traceable back to its original receipt, supplier, and all testing and status changes throughout its life in the facility.
21 CFR 211.84
Unidentified or Mislabeled Material Response Steps
Step 1 - Immediately quarantine the material
Physically segregate and label the material as quarantined the moment an identification or labeling discrepancy is discovered.
Step 2 - Halt any related production activity
Stop any batch operation using material from the same receipt or lot until the discrepancy is resolved.
Step 3 - Investigate the point of failure
Trace back through the material's documented history to determine where the identification or labeling error occurred.
Step 4 - Assess batch impact
Determine whether any batch already used material from the affected lot, and evaluate the impact on those batches.
Step 5 - Correct, re-verify, and document
Correct the identification or labeling error, re-verify material identity through testing if warranted, and fully document the event.
Storage Condition Requirements
Temperature and humidity monitoring
Storage areas continuously monitored against the specific condition requirements of the materials held within them.
Segregation by status and material type
Physical segregation maintained not only by approval status but also between materials that could be confused due to similar appearance or packaging.
Pest and environmental control
Warehouse areas maintained under an active pest control programme and protected from environmental conditions that could compromise material quality.
Restricted access to quarantine and rejected areas
Physical or procedural access controls limiting who can move material into or out of quarantine and rejected storage areas.