Andrea Gruber, head of special cargo, IATA spoke to ACW about the ins and outs of their Centre of Excellence for Independent Validators (CEIV) programme, which was launched back in 2014. CEIV is available to train, guide and support industry stakeholders in Pharma, Fresh and Live Animals.

ACW: What are the benefits of being CEIV certified for businesses and their customers?

Andrea Gruber: When transporting temperature sensitive pharmaceutical products, quality is key and cannot be jeopardised. CEIV Pharma certification ensures that companies meet the regulatory requirements, benchmark their activities towards international, national as well as IATA requirements while mitigating the impact and the risks. Companies that have implemented quality-driven strategy programs such as the IATA Centre of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) programme have a significant advantage in building confidence and trust, in a collaborative environment where the integrity of such sensitive products is maintained throughout the handling and transport journey until it reaches its end customer.

In addition, visibility and transparency of the existing company’s facilities globally is critical especially for manufacturers to identify the level of infrastructure and trained staff at airports to perform their trade lane risk assessment. To address this IATA developed an industry platform “IATA ONE Source” for validated aviation capabilities and infrastructure information, from specific infrastructure requirements such as temperature-controlled rooms to IATA certifications. This information is accessible free of charge on the IATA website and has currently more than 700 companies registered.

ACW: How has the pandemic affected demand for CEIV certification?

Gruber: The coronavirus crisis has exposed challenges that the industry faces pertaining to the capacity of organisations to pivot rapidly to the evolving situation and it also shows the necessity of having globally aligned and harmonised standard when transporting pharmaceuticals. Because of the need to count on reliable partners especially in time of crisis, IATA has seen an increase of demand for CEIV Pharma certification.

Companies involved in the CEIV programme are very committed in making it right and invest time and resources to enhance their processes, infrastructure or other needs as well as committed to continuous improvement. This cannot be achieved in an “express” way, though IATA was asked to create a “CEIV Pharma Light” this was refused as quality cannot be jeopardised and ensuring the visibility of the right players is key in building trust and confidence. 

ACW: What are the benefits for companies to earn CEIV over GDP? 

Gruber: CEIV Pharma incorporates all aspects of GPD and even goes beyond by including other best practices, recommendations, and regulations. The EU GDP chapters and sections remain high level that is why IATA has translated all GDP requirements in detailed questions in the CEIV pharma audit checklist in order to be applicable to the transport industry. In this context being CEIV Pharma certified makes the company GDP compliant.

Here are additional elements of CEIV Pharma, it:

• Incorporates IATA air freight requirements (e.g. TCR)
• Includes requirements set in regulations and standards (e.g. EU GDP, WHO)
• Aims at covering international standards and country-specific requirements depending where the certification takes place
• Focuses on transport, handling and temporary storage that apply to air cargo in areas such as ground/tarmac and aircraft (un)loading, which are not covered by existing GDPs
• Focuses global, consistent, and standardised validations specific for pharma shipment in air freight throughout the supply chain
• Uses an unique CEIV audit Checklist globally
• Is recognised by the industry

ACW: Can you explain the process behind awarding CEIV? What is the audit checklist?

Gruber: The CEIV Pharma approach is twofold, the first phase is an assessment (pre-audit) carried out to review and evaluate current practices, processes, operations, training, and requirements against the criteria set in the CEIV Pharma Logistics Audit Checklist. This checklist is based on the Temperature Control Regulations (TCR), international pharmaceutical regulatory requirements as well as on best practices in risk-based quality management systems. The non-conformities, gaps and findings identified during the assessment will have to be addressed and closed before the second phase namely the validation (audit) is takes place. Therefore, the time needed to close the gaps can vary depending on the findings identified. IATA is following a supply chain approach therefore the CEIV Pharma is relevant to truckers, freight forwarders, airlines as well as to cargo and ramp handlers. The audits are carried out by independent validators with experience in the field of auditing, quality, and operations. Thus, for those shipping pharmaceutical and life science products, the CEIV Pharma programme will provide a reliable quality benchmark.