Driven by Quality
We are fully committed to pursuing the highest global quality standards throughout our organization. These standards ensure our ongoing focus on what matters most to us – Patient Safety.
Our global team places a priority on structured quality systems, procedures and processes across all activities within our organization. Together we strive to provide services that consistently exceed the expectations of both our clients and regulatory authorities responsible for the licencing, audit and inspection of our operations and facilities.
Canada: Health Canada
USA: New Jersey Department of Health (FDA)
Ireland: Health Products Regulatory Authority (HPRA)
EQMS – TrackWise
EZ FMD scanner system
Procurement, Supply, Storage, Import & Export.
General Storage, Ambient Controlled and Cold Chain.
REGULATORY COMPLIANCE AND ENGAGEMENT
The RxSource Global Quality Team is comprised of Quality, Pharmacy and Biochemistry professionals. Our combined expertise ensures an in-depth understanding of all aspects of regulatory and legislative compliance, which is essential to the development and implementation of relevant processes and procedures.
This understanding also places us in an excellent position to engage with national regulatory authorities, with whom we have well established relationships.
RxSource currently holds the following licences globally, which facilitate (as applicable) procurement, supply, distribution and export of Medicinal Products for Human Use and Medical Devices.
Health Canada – (Drug) Establishment Licence (DEL) 101362-A
USA (New Jersey)
New Jersey Department of Health – Drug & Medical Device Certificate of Registration (Wholesaler) 5005473
Health Products Regulatory Authority (HPRA) – Wholesale Distribution Authorisation (WDA) 12184/00001
Reinforcing our commitment to quality, RxSource’s facilities are equipped with state-of-the-art systems that include:
- Dedicated bespoke HVAC and refrigeration units
- Temperature control alarms and monitors
- Critical systems back-up generator power to ensure
product-specific temperature ranges are maintained
Each of our facilities is subject to rigorous routine internal audits that allows us to excel in all levels of external inspections and audits. Security of premises, products and personnel is a key focus to ensure that appropriate access controls and monitored security systems are in place.
How do we certify our teams? All Quality Team members must complete continuous professional development (CPD) and undergo continuous external training and retraining to ensure access to the most up-to-date knowledge and information from each of our competent authorities and those of our customers and vendors.
Once certified, our Global Quality Team, provides in house training to our Operations Teams. Our training program ensures the principals of GMDP are observed and implemented in every aspect of our organization.
To complement our experienced and skilled internal Global Quality Team, RxSource also benefits from the engagement of Quality Assurance Consultants for the provision of ongoing team training and support.
All outsourced business partners complete thorough bona fides and due diligence checks, which are designed to ensure and maintain the quality standards of our service provision and to protect the integrity of our supply chain.
We understand the severe impact of Falsified Medicines. To minimize the risk of exposure, our Global Quality Team have developed and implemented dedicated and thorough systems and procedures throughout our operations and our extended supply chain.
Personnel are trained on Falsified Medicines procedures and the relevant reporting criteria required in the event they identify a product as suspicious. This ensures that such products will not go any further in our supply chain and will be escalated to the appropriate parties as applicable. Items that are identified and confirmed as falsified are immediately tagged for destruction.