Putting pharmaceuticals back in the air
A concentrated effort to improve the level of competency as well as operational and technical prepared ness is urgently required to stop the alarming decline of air cargo’s market share of global pharmaceutical product transport.
The industry identified a need to build a network of certified pharmaceutical trade lanes that meet consistent standards and assure product integrity. As a result, IATA has taken a leading role in supporting the air transport industry to comply with pharmaceutical manufacturers' requirements.
Setting new standards
Working alongside aviation industry stakeholders and regulators, IATA created the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma), to help organizations and the entire air cargo supply chain to get on the right track to achieve pharmaceutical handling excellence.
CEIV Pharma addresses industry’s need for more safety, security, com pliance and efficiency, by the creation of a globally consistent and recognized pharmaceutical product handling certification.
See our CEIV Pharma infographic (pdf)
By establishing a common baseline from existing regulations and standards, this certification ensures international and national compliance to safeguard product integrity while addressing specific air cargo needs.
CEIV Pharma encompasses, or even supersedes, many of the existing pharmaceutical standards and guidelines such as:
- IATA Temperature Control Regulations (TCR)
- European Union Good Distribution Practices (EU GDP)
- World Health Organization Annex 5 (pdf)
United States Pharmacopeia Standards
CEIV Trade Lane Certification
A CEIV trade lane is a general classification of any transport-related activities between two defined countries. A trade lane is CEIV Pharma/Live Animals/Fresh certified if the origin and destination is being linked by CEIV certified transport companies (such as an airline, ground handler, freight forwarder or a trucking company), throughout each stage of the journey from origin to destination (i.e. at no point is the shipment handled or transferred to a non-CEIV certified entity or a subcontracted entity not under the strict SLAs established under the CEIV certification process).
It is also important to note that a company, such as an airline, is not CEIV certified for its network (including all online stations) unless all their stations went through the certification and/or Ground Service Providers have obtained CEIV Certification.
An industry-wide standard
Transporting and handling pharmaceuticals present both challenges and opportunities for all cold chain industry participants.
The business relies on air transport for its speed, consistency and efficiency in delivering high-value, time-sensitive, temperature-controlled products.
However, aviation industry stakeholders must overcome big challenges, such as insufficient expertise, inadequate infrastructure, ill-equipped facilities, and increased regulations, as they strive to provide the high-quality services pharmaceutical shippers expect.
CEIV Pharma ensures that facilities, equipment, operations and staff comply with all applicable standards, regulations and guidelines expected from pharmaceutical manufacturers.
The overall goal is to elevate the industry know-how and achieve global standardization.
Over 200 assessments conducted, over 160 companies have been certified at different locations around the globe. 70+ on-going certifications.
Six shippers in Belgium and two in Spain have given their formal support to the CEIV Pharma program. In addition, the Belgian regulator FAGG – AFMPS have formally endorsed the CEIV pharma program.
CEIV Pharma in the news
- Find out the latest developments about IATA's CEIV Pharma program Download the CEIV Pharm a press clips (pdf).
To get more information on what CEIV Pharma is, its benefits and how to be come certified, please, read the documentation below.
- CEIV Pharma Brochure (pdf)
- How to Become CEIV Pharma Certified (pdf)
- Q&A: CEIV Pharma Recertification (pdf)
- CEIV Pharma infographic (pdf)
- SATS Singapore Implementation Overview (pdf)
- IATA Temperature Control Regulations (TCR)
We offer a broad and diverse number of courses on handling pharmaceutical products:
- IATA Pharmaceutical Handling diploma
- Temperature Controlled Cargo Operations
- Audit, Quality and Risk Management for Temperature Controlled Cargo
- Time & Temperature Sensitive Healthcare Products (e-learning)
IV's Bulletin Board
IATA's Independent Validator's (IV) Bulletin Board lists all the companies which have been CEIV Pharma certified. Once on the page, please select IATA CEIV Pharma in the designation menu.
To get in touch with us for more information regarding CEIV pharma, contact us