GDP Non-Compliance Report for Czech Company D-Pharm
Recommendation
13/14 December 2023
How to conduct and pass GDP Audits and Inspections
Register now for ECA's GMP Newsletter
On 21st July 2015 the competent authority of the Czech Republic has issued a EU GDP Non-Compliance report to a wholesale distributor. According to that report the company D-Pharm located at Makovského námestí 2, Brno, 616 00 does not comply with the Good Distribution Practice requirements.
As the report filed in EudraGMDP (the EU wide GMP and GDP compliance database) mentions, the company D-Pharm seriously violated the conditions on which its permission for activities is based, and they fell short of the obligations set out in § 77 of the Act on Pharmaceuticals. Further details on the concrete GDP findings have not been published.
Source EudraGMDP Database
Related GMP News
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