Pharmaceutical Manufacturing
Manufactures over the counter tablets and capsules for contract customers at the licensed Western Sydney site, working inside controlled rooms to approved batch manufacturing records, with every step checked and signed by a second person.
What the team is accountable for
- Dispense raw materials to the batch manufacturing record
- Operate granulation, compression, coating and encapsulation
- Maintain gowning, pressure and environmental monitoring
- Complete batch records with second person verification
- Raise deviations and participate in change control
How we know it is working
Who works here
Rohan Mehta
Holds responsibility for the Western Sydney licence and its quality system, and joined Orchard Lane four years ago from a generic medicines manufacturer.
Cass Whitmore
Dispenses raw materials and operates the compression suite at Western Sydney, and joined the site two years ago after completing a manufacturing traineeship.
Where the work is recorded
Production Batch Records
Every food, beverage and pharmaceutical batch from planning to release, with line, quantity, status and the notes that support release.
Non-conformance and CAPA Register
Register of every non-conformance, deviation, complaint and safety incident with investigation, corrective and preventive action and closure status.
Raw Material Receipts and Stock
Every inbound lot of raw material and packaging with supplier, quantity, allergen status and quarantine or release status.