The stringent conditions that apply to the storage of pharmaceutical and chemical documentation has inspired a subsidiary of logistics experts Rhenus in Hannover to develop special solutions with these specific sectors in mind. They are designed to meet the requirements laid down by not only Germany’s EMA, BFArm and federal and state authorities, but - where medicines are also subject to control in other countries - also foreign regulatory bodies such as the FDA in the United States and the MHRA in the UK. What’s more, Rhenus Archiv Services GmbH covers a whole series of specific laws and ordinances in Germany, including its Medicines Act (AMG), Medical Products Law (MPG), Drug and Drug Substance Act (AMWHV) - and even the Criminal Code when it comes to data protection for test subjects.
The Berlin-based company stores its pharmaceutical customers' documentation in a secure archive in line with good manufacturing practice (GMP) and good laboratory practice (GLP). Rhenus Archiv Services GmbH has already processed and archived more than 100 million items of sensitive material in compliance with GxP for the pharmaceutical industry. Every sensitive piece of material, from fixed samples from animal experiments through to manufacturing documentation files, is cataloged and stored in specially protected, climate-controlled areas in GLP- and GMP-certified secure archives in Germany and various other European countries. Rhenus provides its document and information logistics services to more than 15,000 customers in Germany and abroad, thus bearing responsibility for over 10 billion documents in total. The company also provides a range of postal services for the pharmaceutical industry, including post rooms to process both physical and electronic incoming and outgoing mail, scanning stations for GxP-compliant digitization of paperwork, and mobile and stationary destruction of files and data storage devices. Apart from physical storage, long-term digital archive solutions are also an option.