Our Quality Management System is deemed essential to the success of Clinigen. It has been designed to mitigate risk around two key areas:
- Falsified medicine
- The appropriate handling of medicines in transit
Our quality system is underpinned by our holding wholesale/distributor licenses around the world, including in the EU, US and Asia-Pacific regions. All of our sites are audited regularly, by a combination of regulators and our pharmaceutical company clients – we see this as a core part of doing business and are very proud of our ability to complete them successfully.
Our key principles
Only the best will do when it comes to patient safety
- Clinigen’s preference is to source products from approved suppliers who operate in line with the EU established GDP/GMP guidelines, which are considered the ‘Gold Standard’ globally. Read more about good manufacturing and distribution practices.
- Products will only be sourced from countries where the product is appropriately authorised ‘on the market’. For example, sourcing products indirectly - such as a German product via a Spanish supplier - significantly increases the risk of receiving falsified medicinal products.
- Brokers of medicinal products will not be used under any circumstances.
We won’t leave you without options
- As a last resort and assuming to do so is legally acceptable in your country, we may also source products from WHO-approved suppliers.
- This flexibility can be essential when supporting healthcare professionals in developing economies, working with Public Hospital Tenders or to alleviate shortages.
- If we are proposing a product from a WHO-approved supplier, we will always be completely transparent about it.
One strike and you’re out
- Medicinal products that have been handled by a provider not holding the appropriate licenses/authorisations or other non-GDP site will not be accepted under any circumstances.
- We maintain an Approved Suppliers List which is a living document and allows us to monitor trends in supplier performance so we can pre-emptively manage risk. New suppliers are subject to a risk-based assessment, which can include on-site audits.
Transparency always wins
- Where medicinal products are obtained from a Wholesale Distribution Authorisation Holder, every effort will be made to ensure that the supply chain is as short as possible.
- Where medicinal products are obtained from a Wholesale Distribution Authorisation Holder, every effort will be made to know the full supply chain and obtain trace-ability back to the manufacturer.
If it’s too good to be true…
- If any medicinal product is offered at a significant discount, the Responsible Person (locally) and the Global Quality Director will review the position before any transaction is taken.
- Large quantities of products being offered, which are in short supply within the market will be investigated before proceeding.
Our quality system ensures that:
- Medicinal products are held, supplied or exported in a way that is compliant with the requirements of the recognised Regulatory Authority in that country.
- Safety information is collected and processed within stipulated timelines and communicated to customers and Regulatory Authorities according to regulatory requirements.
- Employee and management responsibilities are clearly specified.
- Products are delivered to the right recipients within a satisfactory time period.
- Records are made according to MHRA and FDA guidelines for data integrity which refers to ALCOA being Attributable, Legible, Contemporaneous, Original, and Accurate; Deviations from established procedures are documented and investigated.
- Appropriate corrective and preventive actions are taken to correct deviations and prevent them in line with the principles of quality risk management.
- Self-inspections are conducted in order to monitor the implementation and compliance with GMP & GxP principles and to propose necessary corrective measures. Reports contain all the observations made during the inspections and, where applicable, proposals.
Do your other suppliers measure up?