GMP News - Inspections/Audits

EU/EEA inspectors performed almost 2.300 GMP inspections last year. In these inspections they found an increasing number of Non-Compliance Statements.

The British MHRA has published the 2016 GMP inspection deficiency data trend. The report lists interesting examples for all relevant chapters and annexes of the EU-GMP Guidelines.

On 2nd March 2017, the US FDA and the EU (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Such agreements are intended to mutually recognize GMP inspection systems. As a consequence, the GMP Compliance of a site is reviewed by the respective inspection authority. Afterwards, the FDA can use EU inspection results and vice-versa. Read more about the FDA//EU MRA Agreement.

After the Food & Drug Admininstration (FDA) published its final Quality Agreements Guidance end of last year, we now find the first citations in Warning Letters.

The ICMRA has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and FDA.

During an FDA inspection of a Chinese drug manufacturer, the inspector criticized serious and sometimes even bizarre GMP violations  Read more about the Warning Letter to the Chinese Manufacturer Baoying County Fukang Medical Appliance Co. Ltd.

At companies where serious GMP violations are observed, a misconduct of the personnel can often be identified during the inspection. A Warning Letter issued to a Chinese API manufacturer describes attempts to obstruct the inspection as well as some typical violations of GMP with regard to data integrity.