CEIV Support

CEIV Support

CEIV or 'Centre of Excellence for Independent Validators' is an initiative by IATA (International Air Transport Association) to attract pharma shipments into the air freight industry, as the air cargo’s market share in pharma kept declining over the last years.

Therefore the industry wanted to build up a network of certified trade lanes, to assure the quality and the integrity of pharmaceutical products. The program is based upon globally accepted standards and regulations. At the end of the program a certified Independent Validator audits the company.

Two 4Advice staff members are IATA CEIV Independent Validators, which means we certainly know how to obtain the CEIV certificate. We can offer different services to help your company obtain the certificate:

Implementation of the CEIV requirements
On-site assessments
Training and validation
Writing procedures/quality agreements/…
Building up Quality Management Systems (QMS)
In-house support
Temperature mappings
…

4Advice already helped a lot of companies to achieve their CEIV-certification... is your company next?

GDP Support

GDP Support

The export of healthcare products is going through an impressive expansion giving a direct impact on the cold supply chain. To maintain the integrity of all pharmaceutical products the transport industry will have to keep pace with the explosive growth of the health care industry.

Would you like to receive assistance with the implementation of the Good Distribution Practice regulations into your company?

4Advice can give you all the necessary support and information.

We offer a variety of services: optimization of your quality system, support with your processes and procedures, pharma training courses, lane validations, implementation of risk management, ...

Temperature Mappings

Temperature Mappings

A temperature mapping is a study which registers the temperature of certain areas that are being mapped. The purpose of the study is to spot cold and hot spots during operational activities. The collected data provides an essential source of information, to ensure all temperature-sensitive pharmaceutical products are stored and transported correctly within the required temperature range.

A temperature mapping can identify temperature deviations that affect the storage area or equipment. In this case, action needs to be taken. The study should be carried out during extreme weather conditions.

The result of the study will be documented in a temperature mapping report in accordance with the WHO Guidelines. The temperature mapping report is be valid for three years. If during those three years, major changes occur to the equipment, material or storage positions, a new temperature mapping has to be carried out.

4Advice performs temperature mappings on temperature-controlled GDP storage areas, warehouses, trailers, cool dollies, airplanes, reefers, … In case other surfaces, areas of vehicles need to be temperature-mapped: we are always interested in expanding our horizons.

Training

Audit and risk analysis

Lane Qualifications

Lane Qualifications

Understanding the environment through which a TTSPP must travel is essential for successful logistics operations, for package design, and for maintaining the quality of the drug product during external distribution. The best way to understand the temperature hazards that may occur during external distribution is to collect actual temperature data from representative parts of the supply chain. This process dispels assumptions, and can reveal weaknesses, risks and trends within the transport system.

Temperature information gathered from a route profiling exercise can be used to develop representative ambient temperature profiles for specific lanes, modes and durations of transport. Route profiling is a prerequisite for carrying out a statistically representative operational or performance qualification exercise involving shipping containers and refrigerated vehicles. Based on a risk assessment, the lane qualification exercise will be conducted. (Source: Technical supplement to WHO Technical Report Series, No. 961, 2011)

Project Management

Workshop and events

On Thursday, 27 September 2018, 4Advice collaborated with FB logistics to launch its first Drive.Pharma event, which was specifically aimed at logistics service providers who transport temperature-sensitive pharmaceutical products by road.

Transporters, freight forwarders, express services, service providers and pharma shippers were invited to this brand-new initiative. All of them are after all the most important links in the global pharma supply chain and they have made substantial investments in order to comply with the strict GDP-requirements.

The problem is that these companies don’t always receive the recognition they deserve. On the contrary, many transporters who don’t operate GDP compliant or who are not CEIV certified, are often subcontracted to transport pharma products. As this is unfair, the Drive.Pharma initiative searches for solutions. Topics that were discussed on the event were:

How can we facilitate the collaboration between pharma shippers and transporters?
How can we properly acknowledge those who are GDP/CEIV-compliant?
Is there a need for an approved pharma transportation certificate?

Various speakers spoke at this prestigious event, in particular:

Eddy Weygaerts, Transportation Manager at Pfizer
Hugo Van Herck, Director Contract Logistics at Yusen
Frank Van Gelder, Secretary General at Pharma.Aero
Nathan De Valck, Cargo & Product Development Manager at Brussels Airport
Christophe Vandenberghe, Branch Manager at FB Logistics
Geert Verniers, BD Director & Partner at 4Advice

All of them spoke about different topics in the pharma supply chain, which led to interesting insights and constructive discussions. The focus was placed on the GDP/CEIV-certification and the challenges of pharma transportation within the Global Cold Supply Chain. At the end there also was an interactive panel discussion with several speakers and attendees.

Because of the event’s success and positive feedback, we are planning to launch a second Drive.Pharma event, so stay tuned!