IATA Standards: Ensuring compliance to Regulations for Time & Temperature Sensitive Air Freight shipments

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1 IATA Standards: Ensuring compliance to Regulations for Time & Air Freight shipments Ronald Schaefer September 17 th, 2014 Cool Chain Association, Milan

2 Agenda IATA & Air Cargo Regulations & Standards Solution to Challenges Center of Excellence in Pharmaceutical Handling 2

3 IATA & Air Cargo 3

4 About IATA The International Air Transport Association is the industry s global trade association Founded in With 240 members, IATA represents 84% of global air traffic IATA s mission is to represent, lead and serve the air transport industry IATA delivers Standards and Solutions to ensure a successful air transport 4

5 About Air Cargo Scheduled air cargo started 90 years ago with mail Essential engine of today s global economy and airlines business About 48 million tonnes of freight is transported annually with a value of well over $5 trillion $5 trillion only amounts to 0,5% in volume but 35% of worldwide value Consists of general & special cargo e.g. perishables, dangerous goods, live animals, pharmaceuticals, etc. 5

6 Industry Cooperation The Time and Temperature sensitive goods play an important role in this percentage Temperature Sensitive Products Security Safety (e.g. Dangero us Goods) With the healthcare market becoming a key engine of the global economy, pharmaceutical and biomedical industries are facing new challenges in adapting to globalization. Live Animals Special Cargo (ULD, Mail) E-Cargo Speed to market is therefore essential and the healthcare industry is increasingly dependent upon air cargo. 6

7 Industry Cooperation Why is air cargo so important? Immunization prevents 2.5 million deaths every year Air cargo is critical in flying vaccines to their destination in time to be effective. 7

8 Regulations & Standards 8

9 IATA a standard setting organization IATA adopted a supply chain approach by liaising with all stakeholders Temperature Sensitive Products IATA Cargo Services Conference (CSC) Live Animal & Perishable Board (LAPB) Time & Temperature Task Force (TTTF) Shippers Freight Forwarders Ground Handlers Airlines Airports Temperature controlled packaging 9

10 IATA a Standard Setting Organization from the health care industry to establish common standards Temperature Sensitive Products 2007 Perishable Cargo Regulations (PCR) Industry standard 2010 PCR New Chapter 17 New T&T Sensitive Label 2012 Mandatory T&T Sensitive Label Mandatory Standard Checklist IATA - CEIV Pharma 10 Q3 2014

11 IATA a Standard Setting Organization Implementation and Dissemination of Standards Step 1: Implementation Industry feedback driving improvements: Need for standardization in the handling of pharmaceutical products in air cargo environment Need to enhance partnership and communication Need to ensure appropriate training in the supply chain Step 2: Dissemination Support Adoption Prove Concept Develop Standards The industry usually asks IATA to address their needs to ensure compliance and quality services IATA - CEIV Pharma 11 Q3 2014

12 IATA a Standard Setting Organization Dissemination of Standards in the Industry IATA - CEIV Pharma 12 Q3 2014

13 Challenges and solutions 13

14 Background: Pharmaceutical Product Logistics The pharmaceutical industry has relied heavily on the airline industry for its speed and efficiency but air cargo s share of global pharmaceutical products transport has dropped Over the past 10 years, air carriers, handlers and freight forwarders have responded with branded products and services to grab a share of this lucrative and niche market. An external service provider indicated that: nearly 100% of vaccines and 68% of biotech products need to be stored and transported between 2-8 C. 48% of diagnostics and 11% of products from large pharmaceutical companies have to be handled similarly. HOWEVER Air cargo s share of global pharmaceutical products transport (in %) More than 50% of all temperature excursions occur while in the package is hands of airlines. Annual product losses between US$ billion due to various reasons including temperature excursions during transport and shipping. Source: Pharmaceutical Commerce IATA - CEIV Pharma 14 Montreal, September 8, 2014

15 Critical Issues Raised by the Shippers Increasing shift in pharmaceuticals transported by sea due to air cargo challenges Temperature excursions happen while in the hands of supply chain partners Temperature deviation denature the product, render it worthless and be harmful to the health of the patient Products can be lost, scrapped, returned leading to significant costs Due to a lack of compliance, standardization, accountability and transparency across the air transport supply chain IATA - CEIV Pharma 15 The use of air-mode transportation is re-considered unless industry partners ensure quality services Montreal, September 8, 2014

16 Air Cargo Supply Chain Challenges +35 C -10 C +35 C -10 C 16

17 Air Cargo Supply Chain Challenges The process is quite complex and shippers have difficulties to identify stakeholders that meet standards and regulations Example of Flow from BRU to SYD Shipper Forwarder X BRU Forwarder Y SYD Consignee Pick-up In Out In Out In In Out BRU out SIN in out SYD in In Out Ground handler BRU Airline BRU SIN - SYD Ground handler SYD 14 milestones from start to end. HOW CAN YOU MANAGE THIS? IATA - CEIV Pharma 17 Montreal, September 8, 2014

18 Air Cargo Industry Concerns and Challenges No global certification for handling of pharmaceutical products has led to increased regulations and audits Regulations for transporting pharmaceutical products vary around the world Increasing number of regulations around the world to implement and comply with Increasing number of audits Airlines, GHAs and forwarders subjected to multiple audits for handling, transportation and distribution (e.g. WHO Appendix 5, EU 92/25/EEC, IATA PCR Chapter 17 & TCR) No global certification for handling of pharmaceutical products IATA - CEIV Pharma 18 Montreal, September 8, 2014

19 Shippers Expectations in Cold Chain Modal shift is a reality because shippers need products to maintain integrity and efficacy during transportation Compliance, standardization, accountability and transparency across the supply chain Properly trained stakeholders on regulations and standards Adequately equipped facilities throughout the supply chain Global certification for handling of pharmaceutical cargo Common audit format to minimize the disruptions and increase effectiveness Ability to easily search and identify stakeholders that meet requirements IATA - CEIV Pharma 19 Montreal, September 8, 2014

20 Center of Excellence for Independent Validators Improve together to protect and grow our industry The Need for more safety, security and efficiency The solution Develop standards with regulators to raise the bar to (re)gain confidence to improve compliance to standards/regulations Train industry stakeholders on standards and regulation Assess operations against standard check list for independent assessments vs. self-assessments Train independent validators on standards and regulations to identify and recognize the best players Certify and then register best players on a publicly website to harmonize and reduce the number of audits Get States recognition to ensure audits are valid for all IATA - CEIV Pharma 20 Q3 2014

21 Goal of CEIV Pharma Ensure a higher and more consistent level of pharma handling through validations and trainings with registered IVs and instructors EXISTING NEW Training Pre- Validation Standards and (Recurrent Validation (Audit) & Regulations Training) Assessment Award Re- Validation (Re-Audit)* Advocate for globally accepted standards and regulations Establish validation checklist with industry Establish industry steering group Develop training contents Develop assessment criteria for instructors and validators exam Train instructors, validators and industry stakeholders Manage database of certified instructors and validators Develop prevalidation assessment toolkit Develop a standard validation methodology and assessment tool Manage deployment of validators Audit documentation, processes and operations consistently Manage quality of validations Follow-up Award and recognize operators and locations as "CEIV Pharma certified" Manage database of validated locations and operators Manage revalidation schedule IATA - CEIV Pharma 21 Montreal, September 8, 2014

22 Certification Approach and Methodology IATA will certify companies in several steps 1 Preparation 2 Assessment 3 Validation Assemble team; Prepare project logistics; Send data and information request; Send interview request sheet for first visit. 2 weeks before assessment. On-site assessment by Independent validator Assessment versus minimum IATA Temperature Controlled Audit Checklist ; Comparison against best practice; Establish findings and offer recommendations for change; On-site visit by an Independent Validator to review progress made against recommendations during the assessment phase. Drafting of report. Min 6-8 weeks after the assessment. 5 Certification Develop implementation plan and secure resources. Drafting of report. Training: IATA Pharmaceutical Handling Diploma Additional Training IATA - CEIV Pharma 22 Q3 2014

23 Assessment Review, compare against best practice, offer recommendations for change, identify and mitigate risks, develop implementation plan Assessment Criteria applied Quality management Personnel Training Documentation Infrastructure + equipment Operations Complaints, returns and counterfeit Supplier management Self-inspections Transportation Specific provisions for brokers Issues tackled Content of manuals and guidelines Procedures for Audits Procedures for describing packaging systems Acceptance checklist quality and operating agreements Packaging requirements Documentation & labeling Acceptance & control Facilities and equipment Staff training requirements Training adequacy and currency IATA - CEIV Pharma 23 Montreal, September 8, 2014

24 Assessment Focus is on global coverage and universality Assessment IATA guidelines Good distribution practices Local and regional guidelines E.g. Singapore GDP & GDPMDS or FAGG in Belgium CEIV Pharma encompasses various regulations and standards e.g. EU GDP. includes in the check list the GDP requirements. aims at covering international standards and country-specific requirements. aims at reducing the number of audits or simplifying them. 24

25 Assessment CEIV Pharma is looking at a global and consistent GDP+ certification as the GDP is very EU centric and not specific to air transport. Assessment CEIV Pharma aims at global and consistent assessments specific to air transport encompassing international standards as well as national regulations. Local regulations TCR GDP Some areas, such as ground and tarmac transportation, aircraft (un)loading are not covered by GDPs The goal being to have a network of certified trade-lanes assessed consistently. 25

26 Validation Validate if recommendations have been implemented Validation Review of progress on action plan On-site visit by Independent Validators to review progress made against recommendations during the assessment phase. At the end of validation decision on whether all requirements have been fulfilled 26

27 Training: IATA Pharmaceutical Handling Diploma The diploma includes 4 pharmaceutical specialized courses. Upon successful completion of the 4 courses, the participants will obtain an IATA Diploma. Training: IATA Pharmaceutical Handling Diploma Temperature Controlled Cargo Handling Temperature Controlled Container Operations Risk Management of Temperature Controlled Cargo Audit and Quality of Temperature Controlled Cargo 2 key personnel involved in handling pharmaceutical products activities should be trained and pass the examination of the 4 courses of the IATA Pharmaceutical Handling Diploma - before the certification IATA - CEIV Pharma 27 Q3 2014

28 Additional Training Introduction to Time and Temperature Pharmaceutical Products Additional Training 4-6 hours training. Key topics: Pharmaceutical products Processes & procedures related to job functions Identification and labelling Effect of temperature on pharmaceutical products Avoidance of counterfeits Passive and active packing Product security All personnel involved in handling pharmaceutical products activities per station should be trained on IATA Introduction to Time and Temperature Pharmaceutical Products course (or equivalent)) within period of 12 months after the Certification IATA - CEIV Pharma 28 Q3 2014

29 Path to certification Step 1 Assessment Step 2 Training Step 3 Validation Certification!!! Step 4 Training (remaining staff) 29

30 Certification Award Certificate "CEIV Pharma Certified" Example 30

31 SATS Coolport Pilot Project Handover ceremony in February 2014 IATA - CEIV Pharma 31 Q3 2014

32 Certification Timeline (general approach) Preparation 2 weeks Assessment 2-8 weeks Validation 2-4 days onsite Timeframe depends on results of assessment. 2-4 days onsite Certification Training: IATA Pharmaceutical Handling Diploma 2-8 weeks Ideally completed before assessment. Needs to be completed before validation. Additional Training 12 months after certification 32

33 CEIV Pharma Certification Approach There are different approaches to obtain certification Individual approach: One company decides to get "CEIV Pharma Certified" Community approach: A group of companies at an airport decide to get "CEIV Pharma Certified" to form a pharma gateway Coalition approach: A group of companies decide to get "CEIV Pharma Certified" at several airports to form several pharma gateways IATA - CEIV Pharma 33 Q3 2014

34 Advocacy governance Strong emphasis on engaging stakeholder and advocate for endorsement and recognition Industry WHO? Time and Temperature Task Group CEIV Pharma Steering Group TASK Approve standards Approve trainings Global Regional Local WHO FIACA TIACA US GDP EU Global shippers forum (GSF) Cool Chain Association ICQP Local stakeholder associations (Shippers, Freight Forwarders, Ground Handlers, Airlines) Local BARs Endorse + recognize standards Endorse + recognize trainings IATA - CEIV Pharma 34 Q3 2014

35 CEIV Pharma Who s is auditing? Qualification and management of independent validators Qualification IATA conducts preliminary interview with candidate to prequalify candidate for training IVs must undergo IATA training and need to obtain the Diploma for Pharma Handling IVs need to complete Diploma within six months IV s can also become instructors but need to undergo the IATA Train-thetrainer course (optional) Management IVs are registered in IATA database and available to complete the assessments and validations Coordination of IVs is managed by the IATA Consulting team for assessments and validations IV cannot have been in a commercial relationship with entity to be validated 12 months prior to the engagement. 35

36 Recertification Recertification will take place every two year includes assessment and one refresher training plus a validation if necessary "CEIV Pharma Certified" Re-assessment 2 years 2-4 days X Close gaps Validation 1-2 days One Refresher Training e.g. update on new regulations, development on new standards, development of new containers, etc. 36

37 CEIV Pharma Key Benefits The CEIV Pharma is a win-win situation for the industry Shippers Conduct simpler audits of operators Obtain guarantee that products would be handled in line with regulations Experience lower rate of damage and loss due to temperature excursions Be able to prepare their products ready for acceptance Regulators Assured of safety of pharmaceutical products shipped by air Access structured and consistent training and registry of independent validators and assessed operators Airlines, GHAs, Forwarders, Airports Protect and grow revenues in fastest growing segment of air cargo Obtain recognition for operations, facilities and staff after meeting standards Experience simpler audits from various organizations Promote their best practices to the shipper s community IATA Disseminated standards in the industry Common audit criteria and global certification Promote air transport and so limit the modal shift 37

38 Transforming Challenges into Success The importance of partnerships

39 THANK YOU 39

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