60 Seconds with Ronald Schaefer

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The International Air Transport Association’s (IATA) Center of Excellence for Independent Validators (CEIV) Pharmaceutical certification is raising the standards in the handling of pharma air cargo. Air Cargo Week spoke to the project’s lead, Ronald Schaefer, about his role and how successful the programme has been.

Justin Burns, ACW: What is your role in the IATA CEIV programme?

Schaefer: My role is to develop and promote the CEIV Pharma certification programme whose main objective is to improve the industry’s overall levels of competency, as well as technical and operational preparedness via industry and regulator backed training and validation.

However, the programme’s vision is more than simply filling current industry gaps or reducing costs. Rather it is to protect the end users of the various pharma goods shipped by air, for whom swift and unaltered accessibility to vaccines and medications could prove to be a matter of life and death.

Justin Burns, ACW:  Why was the CEIV certification set-up?

Schaefer: CEIV Pharma was set up as a response to the industry’s need for a network of certified pharma trade lanes that meet globally consistent standards and assure the product integrity of the valuable, time and temperature-sensitive pharma products being shipped via air.

Justin Burns, ACW: Who can qualify for this certificate?

Schaefer: All industry stakeholders in the pharma air transport value chain can qualify for CEIV Pharma. Airlines, airports, freight forwarders, ground handlers, and trucking companies, as long as you handle pharma being shipped by air and are committed to provide quality services, you can qualify.

Justin Burns, ACW: What processes do companies have to go through to become certified?

Schaefer: In order to achieve certification, companies must undergo a rigorous training and assessment programme. The path to CEIV certification begins with an assessment by our indepedent validators of cool chain/pharma processes and facilities against international standards, guidelines and regulations. The training consists of two multiple day courses, which cover a variety of topics regarding temperature controlled cargo operations as well as the audit, quality and risk management of temperature controlled cargo.

The final stage, the validation phase, ensures all requirements established during the assessment phase are in compliance and all the gaps and recommendations have been implemented.

Justin Burns, ACW: How many firms are now certified?

Schaefer: There are 16 companies certified and 65 are estimated to complete assessment by the end of the year, with approximately 15 more expected to meet requirements.

Justin Burns, ACW: What difference can CEIV certification make to pharma business?

Schaefer: CEIV Pharma helps firms properly train their personnel, develop adequately equipped facilities, attain compliance with globally recognised standards and benefit from a marketable common audit format that minimises disruption of operations and increases an entity’s probabilities to effectively meet the growing number of governmental regulations and pharma company audits.

CEIV Pharma helps reduce annual product losses (estimated at $12.5 billion worldwide), and mitigates the growing mode shift taking place from air to sea for pharma shipments and the safety benefits that follow from a significant reduction in temperature excursions.

Justin Burns, ACW: Does IATA think that CEIV will help attract more pharma business to the air cargo industry?

Schaefer: Yes. Definitely. CEIV Pharma certification was created alongside both industry stakeholders and regulators in order to keep a fine balance between regulations for the public good and ensuring the sector’s long-term sustainable growth.

Justin Burns, ACW: What feedback has been given by pharma shippers about CEIV certified facilities?

Schaefer: Beginning with our pilot project with SATS in Singapore to the latest certifications completed by BCUBE air cargo and CAL Cargo Airlines, the feedback has been extremely positive.

Even companies who had already been good distribution practice compliant, mentioned that the programme gave them another push towards improving their standards.

The most important feedback is that the programme achieves what is designed for, which is to uncover, and eventually solve, industry wide communication gaps through the application of mutual cooperation, honest sharing of data and a strong emphasis on stakeholder teamwork.