FDA inspection successfully completed

For the fourth time in a row FDA inspection accredits BioChem’s compliance with high quality standards

On November 6th and 7th 2017, a comprehensive GMP system inspection by the U.S. Food and Drug Administration (FDA) was conducted at BioChem Labor für biologische und chemische Analytik GmbH.

As before, this inspection covered different areas of BioChem such as qualification, method transfer, method validation, Excel spreadsheets and -validation, data integrity, stability testing, deviation- and OOS management, change control, CAPA, management review, quality program, training, self-inspection, complaint handling, risk analysis, logbooks, calibration or sample processing.

With the submission of the “Establishment Inspection Report” (EIR) on January 18th 2018, the inspection is “closed”. Following FDA inspections in 2009, 2013 and 2016, this inspection reaffirms BioChem’s high quality standards. This is an incentive for the entire team to continue working day after day in compliance with GMP guidelines.

BioChem’s technical managing director, Dr. Jürgen Branke, thanked all employees for their commitment and their professional and competent performance.

For further information please contact Claudia Eisenhauer, head of our quality assurance unit, Phone: +49 721 9737-151 or e-mail: claudia.eisenhauer@biochem.de