Quality Assurance

Quality is built in, not tested in.

Every Melrose reagent passes through a disciplined chain of checks — from incoming raw materials to finished, released product — so your laboratory gets consistent, dependable results, batch after batch.

Request CoA / QC details Inside our facility

Our QC chain

From raw material to released batch

Incoming raw-material testing

Every key raw material is checked for identity and quality before it enters production.

In-process / production QC

Critical parameters are monitored during manufacturing to keep each batch on specification.

Finished-goods testing

Completed reagents are tested for performance before release.

Batch-to-batch validation

New batches are compared against reference values so results stay consistent over time.

Stability studies

Shelf-life and working-reagent stability are established and monitored.

Release & documentation

Only batches meeting specification are released, each with a Certificate of Analysis.

Standards & controls

Systems that keep quality objective

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ISO 9001 & ISO 13485 practicesQuality-management discipline across processes and documentation.

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WHO-GMP practicesGood manufacturing practice in production and handling.

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DSIR-recognised R&DIn-house research and development capability.

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Levey–Jennings & Westgard rulesStatistical QC principles used to detect shifts and trends.

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TraceabilityBatch records link finished product back to raw materials.

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CAPACorrective and preventive action to continuously improve.

Support for your lab

Controls, calibrators & documentation

Beyond reagents, we supply control serum and calibrators and provide the documentation your laboratory needs for its own quality programme.

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Control serum

Normal and pathological control sera to verify day-to-day performance.

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Calibrators

Multi-analyte calibrators for accurate, traceable results.

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Certificate of Analysis

Batch-specific CoA available on request for released product.