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TGA-licensed manufacturer · Brisbane

Prescription medicines, released with evidence.

Halden manufactures and tests prescription medicines in Brisbane, and every batch moves through one release board: sampled, tested, reviewed and released, with the record attached at each step.

  • GMP licence [placeholder]
  • In-house QC laboratory
  • Released in Australia
H
Halden QCHT-2611-07 · lab
What we do

Made, tested and released under one roof.

Halden makes prescription medicines for supply through licensed pharmacies, and runs its own laboratory so every result is ours to stand behind.

Every result, against its limit.

A batch record holds dozens of tests. Filter by kind to see what a typical record checks.

Assay, component A101.4 %90–110 %
Related substances0.38 %≤ 2.0 %
Total aerobic count< 10 cfu/g≤ 10³
Fill volume25.4 mL25.0–26.0
Residual solventsConformsICH Q3C
Yeasts and moulds< 10 cfu/g≤ 10²
AppearanceConformsVisual

Pharmacies can check any batch.

Every released batch has its certificate online.

Pharmacylookup · 10:02am
HT-2611-02 · released 14 Nov · certificate attached

Procedures, kept current.

Every change to a procedure is reviewed, approved and trained before it's used.

QualityBatch releaseSampling
Quality / Batch release
SOP-QA-014, revision 7
Approved · training complete

Supplied only on prescription.

Released batches go to licensed wholesalers and pharmacies, and are dispensed only on a prescription.

Shipment · HT-2611-02 · sample
pickedReleased stock · cold room 28:10
checkedLicensed wholesaler · order matched8:42
dispatchedTemperature logger on9:05
A batch's journey

From sample to release, logged at every step.

A typical release day for one batch, from the batch record.

batch record · HT-2611-07 · sample
product MP-12 · size 4,800 units · site Brisbane, suite B
07:40Samples drawn to the plan · 12 containers
08:15Chemistry and microbiology started
11:3038 of 38 results inside their limits
13:05Record reviewed line by line by QA
14:20Released · certificate published
HT-2611-07 · release day
Sampled to the plan
Tested in our own lab
Reviewed by quality assurance
Released with its certificate
Sample record

Batch numbers and results are illustrations for this template.

Bring us a product. We'll bring the evidence.

Technology transfer, clinical supply and commercial manufacture. Our business development team replies within two working days.

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