By Sofrigam S.A
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Sofrigam to present data integrity solutions at TIPS Lyon
Rueil Malmaison, France: – Temperature-controlled logistics and pharmaceutical cold chain packaging specialist Sofrigam S.A. will discuss data integrity issues in transporting healthcare products and present a range of solutions that apply to cool chain logistics at the upcoming TIPS seminar in Lyon, France.
Sofrigam will be a high profile presence at the two-day International Transport of Healthcare Products seminar opening November 20, with an exhibition stand at Booth B32 at Lyon’s Cité Internationale, showcasing its extensive range of pharmaceutical insulated packaging.
The importance of ‘Data Integrity’
The TIPS 2018 seminar recognizes that integrity of data during transportation of pharmaceutical products, in accordance with Good Distribution Practice (GDP, has become an increasingly important issue in healthcare. Backed by non-compliance sanctions that can extend to suspension of import licenses, this good practice has now become an essential requirement of the pharmaceutical quality system.
Data integrity means assuring accuracy and consistency of information and maintaining it over the entire product lifecycle, This has become a central concern of regulatory authorities worldwide as the key component in assuring the security, efficacy and quality of medicinal products, with draft data integrity guidelines published by the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Complying with GDP/GMP requirements
Over the last few years, the FDA has documented an increasing number of violations involving data integrity and, during 2015 alone, issued more than 50 warning letters following findings of violations related to data integrity, some 80% of them from outside of the United States. Similarly, in Europe, the authorities (ANSM, etc.) have raised non-conformities as well as orders relating to deviations to the integrity of data in respect of healthcare companies.
From the collection of data to its transfer and storage, pharmaceutical and biotech supply chain and logistics quality systems must ensure the security of data, extending from manufacturing to final distribution, in accordance with Good Manufacturing Practice (GMP) and GDP guidelines.
Data integrity in cold chain logistics
The international transportation of healthcare products engages the responsibility of the manufacturer to ensure the security, efficacy and quality of medicinal products throughout the distribution chain, until they reach the patient.
This is particularly so when it comes to distributing temperature-sensitive pharmaceutical and biotech products in which the ‘data chain’ describes not only product identity and manufactured quality but also its cool chain integrity.
Products that must be transported at controlled temperatures, whether cold or cool, face specific risks related to temperature excursions (too warm or too cold) and breakdown of constant temperature monitoring that makes quality unquantifiable .
Preventing these risks means choosing reliable and secure insulated packaging solutions, equipped with data recording tools during transport. Sofrigam designs and manufactures a range of insulated and refrigerated packaging solutions that incorporate data logging and monitoring technologies, such as the ‘intelligent’ iBox temperature-controlled container that include networked monitoring. Compliant with GDP Guidelines, the iBox packaging offers a high-technology, innovative and green solution to secure the shipping of pharmaceutical products, enabling the monitoring of data during transportation.
In order to meet the requirements of the pharma supply chain, Sofrigam also provides a range of data loggers that can be used with cold chain packaging. These are incorporated in the packaging before shipping, the data can be collected very easily and some of these temperature recorders can be re-used many times.
Sofrigam will show the TIPS seminar how such solutions can be combined to meet the shipping needs of medicinal products across the entire supply chain, right up to the last mile, while also providing data integrity throughout.
Sofrigam’s packaging solutions meet the standard and regulatory requirements specific to the transport of healthcare products.
Its team at TIPS Lyon is prepared to present a holistic approach to data integrity challenges, based on methodical risk analysis.
With over 40 years of experience, Sofrigam provide a comprehensive portfolio of innovative packaging and related solutions that allow pharmaceutical and other clients to optimize their temperature-controlled logistic chains.
From its French roots, Sofrigam has become a global company, operating in the USA, Canada, UK and across Europe, with manufacturing centers in North America and Europe.
Sofrigam manufactures a range of standard and made-to-measure thermal packaging products, including cartons, cases, bags and pouches that cover every step in the cool chain, from manufacturer to end-user.
It also offers customized services designed to achieve secure, cost effective and ecological cold chain logistics in shipping, storage and packaging.
Sofrigam Services accompany clients through every step of the logistics chain while prioritizing safety of goods and reducing costs. Advanced software and other solutions allow clients to audit their cold chains, monitor shipments, analyze logistics lanes, manage Inventory and optimize ordering.
Sofrigam can also deliver best Time to Market through thermal simulation equipment combined with its ‘cut & glue’ customization process that gives customers the ability to adapt any catalog product to its own needs with development time reduced to as little as 15 days.
About TIPS 2018
The annual International Transport of Healthcare Products seminar (TIPS) is organised as a symposium by and for the pharmaceutical industry by the Pharma Logistics Club (PLC), an inter-professional association established in 2015.
TIPS brings together more than 100 companies internationally in the healthcare supply chain. With pharmaceutical companies, carriers and logisticians, as well as equipment providers, it unites key players from around twenty diverse but complementary sectors in the supply chain of pharmaceutical products.
TIPS 2018 is a two-day event opening November 20 at the Renzo Piano-designed Palais des Congrès de Lyon in the Cité Internationale district and is expected to attract more than 500 participants. The 2018 theme will focus on data integrity within Good Distribution Practices.
Further information at: http://pharmalogistics.club/?lang=en