The GDP Non-Compliance Reports of 2021 - An Overview
Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority. If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. For your information please see the comprehensive overview of the GDP non-compliance reports entered in 2021 and the respective reasons for issuing them.
Revised IPEC GDP Audit Guide for Pharmaceutical Excipients Available to the General Public
In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.
GDP Non-Compliance Report for German Wholesale Distributor: No GDP Conform Quality System and No Suitable and Adequate Premises
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 Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.
Q&As from the EMA Webinar for Industry on Integration of EudraGMDP and OMS
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.
As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.
In 2021 again Numerous FDA 483s due to Deficiencies in the Stability Program
Only recently, we reported that in fiscal years 2019 and 2020, deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. The FDA has now published the data for the fiscal year 2021. About a fifth of the 483s revolve around the issue of stability.
The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.
Inspection Deficiencies in Process Equipment increase
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.
Particles lead to Warning Letter for Japanese Sterile Manufacturer
The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.