Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
CEIV Pharma IATA
Global Air Transportation Industry
We’ve all heard of the European Commission for GDP, the MHRA Green Guide and the Human Medicines Regulations 2012 but who is regulating the expansive Global Air Transportation Industry?
Have you ever heard of the IATA Temperature Control Regulations? If not, don’t be worried – it’s not as well known.
The IATA CEIV Pharma certification (or IATA Centre of Excellence for Independent Validators in Pharmaceutical Logistics) is provided by IATA, enabling those transportation providers to undergo a regulated audit programme, to ensure adherence to strict GDP compliance, quality management and handling controls when distributing pharmaceutical products.
The IATA CEIV Pharma standards are comprised of the IATA TCR alongside the main GDP requirements from around the world, and subscribing to the certification will ensure international compliance. It’s not an easy process; and nor should it be: IATA CEIV Pharma is designed to protect the integrity of pharmaceutical product whilst being shipped across multiple continents, providing a high level of quality assurance to pharmaceutical exporters & importers that their logistics provider can meet their own regulatory requirements for outsourced activities.
Millions of tonnes of pharmaceutical products fly from one end of the globe to the other each day, passing through the hands of dozens of people, suppliers, and even crossing seasonal barriers. Fortunately, a certification programme is available for providers of transportation services such as airlines, ground handling agents, freight forwarders and 3PL facilities.
Benefits of IATA Pharma CEIV
- Gain a wealth of knowledge and expertise into applying GDP to international air transportation.
- Ensure compliance with all national and international regulations and standards.
- Protect the integrity of the pharmaceutical supply chain.
- Become recognised as an IATA CEIV Pharma station, gaining access to the logo for company marketing.
- Increase efficiency and reduce costs. Applying clearly defined and harmonised processes will simplify your operation, whilst increasing handling capability of temperature-controlled pharmaceutical cargo.
- Acquire a competitive advantage over other logistics providers (a regulated supplier wins every time!)
The Certification Process
Certification is possible across multiple or as an individual site. It’s not as straightforward as other certifications such as ISO, but the benefits of being accreditation more than make up for it.
To simplify, you will sign up to the CEIV programme with IATA and receive the IATA CEIV Pharma standard, alongside a 300+ line checklist to which you must perform a self-inspection against.
Once you feel confident you can meet the standards, you organise with IATA what they call the ‘initial assessment’. An independent validator will then attend on-site and audit your organisation against the checklist. An audit report will be issued with any findings raised. The organisation will then have a maximum of 12 months to close the highlighted findings and undergo the ‘final validation audit’.
Again, an auditor (different than the first, IATA operate under a ‘4 eyes’ principle) will attend on-site and audit you against the checklist again, concentrating on the NC’s highlighted by the initial assessor.
If they feel you have closed the outstanding findings and meet their high standards, congratulations! You have obtained IATA CEIV Pharma certification status.
If you’re interested in obtaining the IATA CEIV Pharma certification, we can get you through it! Whether its quality management system implementation, process building or even good old-fashioned consultancy, we’ve got this!
You can call us on 0330 133 0920 for a free initial consultation and advice, or use the contact form below to get in touch. Alternatively, drop us a line on info@gdptraining.co.uk