Image may be NSFW.
Clik here to view.
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:
Image may be NSFW.
Clik here to view.
The integrity of data is currently in the focus of international authorities In particular the US FDA issued serious violations in Warning Letters to the companies concerned. Read more about the current complaints in a Warning Letter issued to the API manufacturer VUAB Pharma.
Image may be NSFW.
Clik here to view.
http://www.gmp-compliance.org/enews_04898_FDA-Warning-Letter-on-Data-Integrity_9363,9267,Z-COVM_n.html
For authorities the integrity of data is an essential quality attribute in the manufacture of pharmaceutical products. After some serious deviations international authorities have moved the topic into the centre of their interest. In particular the US FDA issued serious violations in Warning Letters to the companies concerned.
Image may be NSFW.
Clik here to view.
In a current letter to the API manufacturer VUAB Pharma in the Czech Republic the inspector and the authority criticised multiple aspects with regard to “failure to prevent unauthorized access or change to data and to provide controls preventing data omissions”:
- ‘The firm did not retain complete raw data from testing performed to assure the quality…
View original 408 more words
Filed under: Uncategorized Image may be NSFW.
Clik here to view.
Image may be NSFW.Clik here to view.
Image may be NSFW.Clik here to view.
Image may be NSFW.Clik here to view.
Image may be NSFW.Clik here to view.
Image may be NSFW.Clik here to view.
Image may be NSFW.Clik here to view.
Image may be NSFW.Clik here to view.
