Quality Management - Clinical Trials Facility


Cryosite’s purpose built, modern facility is licensed by the TGA (Therapeutic Goods Administration) of Australia and is GMP (Good Manufacturing Practice) certified to support the specialised needs of highly regulated, temperature-sensitive products.


We take our quality obligations and responsibilities seriously. Cryosite maintains accreditations, has thorough knowledge of regulatory systems and utilises best-in-class management systems to ensure our quality processes.


TGA License number MI-18072008-LI-002488-11

 

Cryosite is audited regularly to ensure our storage facilities meet TGA standards.

 

Department of Agriculture (DOA) – Approved Arrangement for imported goods

 

Cryosite has DOA approval to self-manage biosecurity risks and documentation associated with importing clinical trial supplies. We are diligent in maintaining this arrangement through excellence in training, accreditation, monitoring and compliance.

 

NSW Health – Good Wholesaling Practice (GWP) for Scheduled Medicines OHF1472 AND OHF1473

 

Cryosite has wholesaler licensing arrangements with NSW Health under the Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8. Under this Code of Practice, Cryosite ensures a high-quality supply chain through effective, efficient and safe handling, storage and distribution of medicines.

 

Regulatory knowledge


Cryosite has 20 years’ experience in working with regulatory and statutory authorities. Combined with our deep knowledge of the clinical trial cycle, we can guide clients through the processes required for permits and licenses.


e-PQS quality management systems


Cryosite’s quality management embraces the key systems of quality assurance and quality control. Quality control is an integral part of our daily operations to ensure quality requirements are fulfilled for each part of the clinical trial logistics process. In turn, our quality assurance provides you with confidence in our quality control by documenting compliance with protocols, Good Clinical Practice (GCP) and relevant regulatory requirements. 


Regular internal and external audits of our quality management systems are performed. In turn, our quality management systems provide full audit reporting to national and international pharmaceutical companies and CROs.


Safety and security

 

Cryosite uses cutting edge technology to maintain the safety of your stored products in our secure and fully monitored facility.

 

Facility security

 

Secure electronic access ensures only authorised persons are permitted into areas where products are stored. The facility has 24/7 surveillance and security, with internal and external systems.

 

Data security


Your company information and client records are secure. Cryosite’s IT systems are monitored internally and externally and backed up each day to local on-site servers. 


We have the latest IT security and cyber security software – using AI (artificial intelligence) to protect against cybercrime.


Power generator back-up


Cryosite’s facility has a back-up generator providing continuity during power outages.


Specialising in:

  • Vaildated e-Pharmaceutical Quality Management System
  • Validated Warehouse Management System (WMS)
  • cGMP, GDP, GWP compliant processes
  • Controlled storage (15 - 25°C)
  • Controlled drugs storage (15 - 25°C)
  • Cold Room storage (2 - 8°C)
  • Cold Room S8 drug storage (2 - 8°C)
  • Frozen storage from -80°C to -20°C
  • Cryogenic storage in LN2 -150°C to -192°C
  • Re-labelling
  • Secondary packaging
  • Comparator sourcing
  • Returns management
  • IVRS management
  • Reconciliation, destruction and recalls
  • Designated areas for quarantined/high-level security storage

  • Online visibility