Stop 1
Quarantine and testing on arrival
Every drum of raw material is held in a caged quarantine area until our laboratory confirms its identity and purity. Suppliers are audited every two years.
Stop 2
Dispensing
Materials are weighed in a downflow booth. One operator weighs, a second checks and signs, and the balance prints a label for the batch record.
Stop 3
Making
Mixing, granulating, pressing, filling. Each step has set times, temperatures and speeds, recorded automatically and checked by the supervisor.
Stop 4
In-process checks
Weight, hardness and fill volume are checked every 30 minutes on the line. A result outside limits stops the machine.
Stop 5
Laboratory release tests
Assay, dissolution, microbial limits and packaging tests on every batch, against the pharmacopoeia and our own tighter limits.
Stop 6
Release by a pharmacist
A qualified pharmacist reviews the full batch record and signs the batch out. Only then is it published to the batch check.
