Not Approved Storage Facilities lead to GDP Non-Compliance Report for Czech Wholesale Distributor
Recommendation
Thursday, 9 September 2021 9 .00 - 18.00 h
Register now for ECA's GMP Newsletter
The competent authority of Czechia (State Institute for Drug Control) has entered a new GPD Non-Compliance Report into the EudraGMDP database.
During an inspection conducted in November 2020 at a Czech wholesale distributor, it came out that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC. As a consequence, the wholesale permission was suspended.
According to the Czech authority, "the company has seriously violated the conditions on which is the permission for activities linked and fell short of the obligations set out in Section 76 of the Act on Pharmaceuticals. [...] The WDL was suspended in full due to the fact, that the company does not provide approved storage facilities."
Source: EudraGMDP Database (Report Number: sukls268540/2020)
Related GMP News
01/06/2021
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others