Non-Compliance Report for German Wholesale Distributor Published
Recommendation
22-24 June 2021
Register now for ECA's GMP Newsletter
The competent authority of Germany (Department of Occupational Health and Safety, Customer Protection and Health) has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the discovery of serious GDP non-compliance at a German wholesale distributor.
During an inspection conducted on 18 November 2020, it came out that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC.
"The main reasons were non-GDP-compliant storage conditions without temperature control and access protection or pest control, as well as serious deficiencies in the area of documents (no QMS established, which corresponds to the requirements of the GDP guide). Furthermore, no documentation for the activities carried out could be presented to the inspectors"
As a consequence, the wholesale permission was suspended.
Source: EudraGMDP Database (Report Number: 20200112_G3-6300-GH/B&V)
Related GMP News
01/06/2021
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity