IBR Inc. based in Matzingen, Switzerland is a contract research institute in the field of biopharmaceutical research, and has been covering bioanalytics demand from pre-clinical to clinical research to date. In order to meet customer requirements in the product approval segment as well, the company planned to expand the quality system to meet the corresponding GMP requirements in 2019.
The gempex consultants engaged for the project closely examined the laboratories and process flows based on a detailed study of the current situation. After verification of the gap analysis, the resulting to-do list was discussed together with the employees involved on site. The recommendations encompassed conversion measures for the facilities and some additional technical measures, the preparation of documents relevant for GMP and the use of a new document management system. After implementing the recommendations, the GMP experts from gempex conducted a mock inspection to prepare for the upcoming official inspection by Swissmedic.
Thanks to the preceding, perfectly organised GMP upgrade performed by the GMP service provider gempex – true to its motto “As much as necessary, as little as possible” – IBR Inc. was awarded its GMP certificate by Swissmedic in February of 2019. Since then customers of the contract research institute know they are in the best hands from pre-clinical research to product approval.
You will find a detailed project description here (German language).