High standards ensured for Pharma cargo

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Compliance, competence, and preparedness are key words for the transport of pharmaceutical goods by air. A new certification by IATA ensures that airlines meet the precise levels of compliance.

The International Air Transport Association (IATA) has introduced a certification aimed at reassuring the pharmaceutical industry that airlines can transport their products to the required standards—and Finnair is the first airline to receive the certification.

In June 2015, Finnair Cargo welcomed the auditor for IATA’s CEIV Pharma (Center of Excellence for Independent Validators in Pharmaceutical Logistics) certification to Helsinki Airport. According to Jussi Mattila, who together with Cargo Services Manager Henry Rantala accompanied the visit, the process went smoothly, and Finnair Cargo was able to confirm its high levels of competence and preparedness.

“The audit process is a holistic approach to airline and cargo warehousing operations. It has elements found in ISO, IOSA, and ISAGO standards for management, quality management, and Key Performance Indicator feedback of the organization. The actual audit is performed based on a long checklist of questions relevant to transport of pharmaceuticals, and the scope varies depending on the operations,” explains Mattila. He also adds that the IATA CEIV standard differs from the more familiar ISO audit where Yes/No responses to questions are required. 

The holistic nature of the audit did not come as a surprise to Mattila, but it did require a considerable amount of preparation. He pays tribute to all the stakeholders who cooperated in the validation process. 

“It’s a challenge since we have to involve all service providers from facility services to flight operations, and not just our own organization. Internal cooperation is essential, and I want to thank everyone who has been involved.”

Thorough training and preparation

Mattila tells that the process begins with preparation in reference to the checklist, and training of key personnel. “Training is important, and the validation standard is rather open. To gain the required knowledge, trained and qualified people are needed. Once that knowledge has been acquired, the requirement instructions, standard operating procedures, and quality management models can be created around the CEIV requirement.”

“After initial preparation, an accredited CEIV validator performs a pre-assessment that covers everything: quality management process, operational processes, instructions and standard operating procedures, training programs, agreements with stakeholders involved, and corresponding service level agreements,“ explains Mattila.

According to Mattila, this pre-assessment is a vital gap analysis that must be used to achieve full compliance. The final stage is the official validation that assesses the work done against the validation checklist, and the gap analysis done during the pre-assessment.

Learning experience for the organization

Mattila is satisfied that the validator’s visit at Finnair Cargo went well. “We truly focused on the whole process with great precision. As I said, this is a validation rather than a standard audit, so feedback and dialogue were constant and beneficial.”

There was also a learning element in the validation. “On preparation and implementation the required tasks and duties must be embedded in existing organization structures rather than creating an isolated team. This integration will ensure good quality working habits for the whole organization,” says Mattila.

As the first airline to receive the certification, Finnair can be proud of this merit. “The IATA CEIV Pharma is a major milestone for air cargo, in general. It ensures a uniform approach within the air cargo industry, and increases transparency of the air cargo logistic chain to the pharmaceutical industry.” 

Mattila tells that the initial steps have now been taken, but the work continues. “As with most quality standards, this one also includes a re-validation process. The next one will be in two years from the initial certification.”

Text by Tim Bird
Photo by iStock

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Published July 2, 2015

Category: Collaboration, Finnair Cargo

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