Quality standards

Our Quality Management System is deemed essential to the success of Clinigen. It has been designed to mitigate risk around two key areas:

  1. Falsified medicine 
  2. 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.

Learn more about regulatory pathways

Learn more about reducing the risk of receiving a counterfeit medicine 

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.

Explore our popular questions for further information on how Clinigen Direct can help.

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.

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