After assessing the archive centre in Munich-Allach in June, the Bavarian State Office for Health and Food Safety certified that the Rhenus Office Systems archiving centre met the GLP standards as an assignment archiving centre. The archives may therefore now store documents from GxP-regulated areas at pharmaceutical companies. GxP refers to the guidelines for “good working practices”. They include documents from research, development and the production of medication and active ingredients.
After Leverkusen, Grossbeeren and Frankfurt, the multi-user archives in Munich are the fourth GLP-certified business site for Rhenus Office Systems. “Having our archives audited in line with the strict GLP guidelines is very important for our customers in the pharmaceutical industry. We can now serve our customers in south Germany and particularly in Bavaria to an even better degree,” says Claudia Hobohm, Managing Director of Rhenus Office Systems, giving the reasons for the decision to have the premises certified.
The archiving centre in Munich has 14,000 square metres of storage space; it has been providing all the services related to archiving files, including a daily courier service with Rhenus’ own vehicles, and digitisation since 1998. In addition to GLP certification, the archives have also been audited in line with ISO 27001 (information security) and ISO 9001 (quality management).
Good Laboratory Practice is a quality certification system, which deals with the organisational procedures and general conditions; these include planning, conducting and monitoring non-clinical health and environment-related safety checks; the audits are recorded, archived and reports are published. Its guidelines were drawn up by the Organisation for Economic Co-operation and Development (OECD).
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