Quality, regulatory and governance framework
HL Pharma is an ISO 9001:2015‑certified pharmaceutical storage, distribution and third‑party logistics partner, operating a purpose‑built, temperature‑controlled facility in Melbourne and associated national distribution operations. We work under PIC/S Good Distribution Practice (GDP) and the Australian Code of Good Wholesaling Practice (GWP), with services focused on compliant storage, distribution and Importer of Record activities.
HL Pharma does not hold a TGA GMP manufacturing licence and does not perform GMP‑licensed manufacturing or secondary packaging activities.
The framework combines certified quality management, state and federal licences and permits, recognised regulatory pathways, and alignment with Good Distribution Practice and Good Wholesaling Practice to support compliant, temperature-controlled pharmaceutical logistics across Australia, New Zealand, and the wider Asia Pacific (APAC) region.
Area
HL Pharma position
ISO 9001:2015 certification
HL Pharma is ISO 9001:2015 certified by BSI (Certificate FS819588) for the distribution and sponsorship of pharmaceuticals, medical devices and other therapeutic goods. The certified scope covers sourcing, warehousing, and temperature-controlled storage and handling of licensed and unlicensed products, including clinical and post-clinical trial supply, Managed Access Programs, and the provision of critical medical supplies during shortages or emergencies, with a particular focus on regulated medicines in Schedules 2, 3, 4, 8, and 9. We chose BSI as our certification partner because it is globally recognised and its rigorous approach aligns with our commitment to high-quality, consistent and auditable processes across our Melbourne facility and national distribution operations.
Electronic Quality Management System
ISO 9001:2015 certified electronic Quality Management System is aligned with Good Wholesaling Practice and Good Distribution Practice, covering warehousing, temperature-controlled storage, inventory management, dispatch and customer service. The system controls SOPs, training and competency, deviations and CAPAs, change control, document management and audits, with traceable records and electronic signatures consistent with 21 CFR Part 11 and EU Annex 11, supporting data integrity, traceability and audit readiness.
Victorian Department of Health Licences
Licensed by the Victorian Department of Health for the storage and handling of scheduled medicines relevant to our services, including Schedules 2, 3, 4, 8 and 9, with defined requirements for physical security, access control, record keeping, stock reconciliation and investigation of any discrepancies involving high risk and controlled products.
Controlled Substances and ODC Permits
Office of Drug Control import and export licence for narcotic and psychotropic substances, with direct coordination to obtain and manage permits for the import, export and handling of controlled medicines so that all activities meet Australian legislative, permit and reporting requirements.
Alignment with GDP and GWP
Practical experience supporting key TGA access pathways, including clinical trial supply, Section 19A arrangements, Special Access Scheme, Authorised Prescriber, Managed Access Programs and compassionate supply. This is underpinned by documented quarantine and release controls, clear deviation and excursion management, and inspection-ready records that withstand sponsor and regulator review. Clients also benefit from audit support and portal visibility across stock, batches and orders for both licensed and unlicensed medicines in Australia, New Zealand and the wider APAC region.
Regulatory Pathways and Experience
Practical experience across key TGA pathways, including clinical trial supply, Section 19A arrangements, Special Access Scheme, Authorised Prescriber, Managed Access Programs and compassionate supply for licensed and unlicensed medicines into Australia, New Zealand and the wider APAC region.
Specialist Regulatory and Safety Partners
Collaboration with specialist regulatory and pharmacovigilance partners for activities such as registration and ARTG maintenance, post market safety and related regulatory reporting, complementing HL Pharma’s licensed, temperature controlled storage and distribution services.
This integrated quality and regulatory framework underpins HL Pharma’s temperature controlled storage, clinical and post clinical trial supply, Managed Access and compassionate supply, controlled drug storage and commercial pharmaceutical logistics, providing an audit ready and dependable platform for manufacturers, sponsors, CROs and healthcare providers in Australia, New Zealand and the wider Asia Pacific region.