GMP News - Inspections/Audits

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers' team.

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 03 December 2021 into the EudraGMDP database. Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.

At the beginning of October, we reported on important changes for entries in the EudraGMDP Database. To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The EMA has now published a 13-page Q&A document with 87 questions raised during that webinar.

With Dr Robert Califf, President Biden has now nominated an expert in clinical trials who has previously served as an FDA Commissioner.

An interesting case of two fires occurred at an API manufacturer in the USA. This is described in a Warning Letter from the FDA that was recently published.

Supplier qualification, contracts and quality oversight are also important to the FDA. This is reflected in a recent Warning Letter from the authority.

The US FDA reports deficiencies during inspections in the so-called Form 483s. These reports are partly public, and the FDA subjects them to trending by key points. The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment.