Schmitz Cargobull Telematics’ TrailerConnect unit and the telematics service portal are now certified ‘Good Distribution Practice of medicinal products for human use’ (GDP) compliant, according to Managing Director, Marco Reichwein.
He said that TÜV SÜD tested the hardware and software, certifying both as GDP-compliant at the end of 2018.
The pharmaceuticals industry has been growing rapidly worldwide for years, according to Schmitz Cargobull Telematics. In Germany alone, sales in 2017 were €41.5 billion (an increase of five per cent over the previous year).
Transport volume and demand for end-to-end monitoring and documentation of the supply chain is also reportedly growing in parallel.
The European Commission introduced GDP for quality assurance and protection against counterfeit medicines. Manufacturers, pharmaceutical wholesalers and pharmacists must have their processes GDP-audited annually.
“With our GDP certificate we can ensure and document comprehensive process safety over the entire supply chain from the recording of the data in the trailer and its storage through to its presentation in the portal or its transmission in the API (interface for the transfer of data to third-party systems),” said Schmitz Cargobull Telematics Product Manager, Hendrik Voth.
As part of the auditing, the following subject areas were viewed in detail: interface description, data storage, data protection, risk analysis for software development / software updates / data protection, the software manual, sensor specification, company description, the management report for 2017 and the ISO 9001.
“In contrast to many other companies, we now possess an official certificate with a test and accreditation number from TÜV SÜD,” said Voth. He added that this is valid for a period of two years.
“Our customers can, of course, request this certificate from us for their GDP audit,” said Reichwein. “This saves them additional expense and allows them to demonstrate they are now fully compliant with regard to safety documentation for the entire supply chain.”