“Triple – NAI” – FDA inspection accredits BioChem for the third time in a row: “No Action Indicated”
On January 18th and 19th of 2016, another GMP inspection was conducted by the US-American FDA. After detailed examinations, the inspector reached a very positive result. “No Action Indicated – NAI” was the final conclusion. This completed the regulatory inspection without any objections for the third time in a row after 2009 and 2013. The fact that BioChem achieved this in three consecutive inspections was said to be evidence of the continuous “high performance” in all areas of the company.
The extensive GMP system inspection involved all areas of BioChem. The audit agenda included issues such as qualification, method transfer, method validation, Excel worksheets and -validation, data integrity of excel sheets, stability tests, deviation- and OOS management, Change Control, CAPA, management review, quality program, training, self-inspections, complaints handling, risk analyzes, logbooks, calibration or sample processing and many more. For each topic, the quality standards were substantiated by examples and the processes shown and explained in detail.
“We are pleased that we comply with the high standards of the FDA with our quality management system and our daily work,” the Technical Director, Dr. Jürgen Branke, emphasizes. “At this point we would like to especially thank our employees for their commitment and their professional and competent performance.”
This success is an enormous incentive for the BioChem team to further expand their position at the qualitative top of biochemical laboratories in Germany and abroad. The “Triple NAI” shows that a solid base has been created to achieve this.