Thursday the 28th November 2013
On 5 November 2013 a revision to the GDP Guidelines, which completely replaces the version that was issued in March 2013, was published. The November version, which became effective on 24 November 2013, corrects factual mistakes identified in sections 5.5 and 6.3 of the March 2013 Guidelines.
... Read more
Wednesday the 27th November 2013
Improve patient safety and avoid costly product-launch delays
By Kurt L. Moyer and James R. Scull, NSF Health Sciences
Well-documented incidents of contaminants leaching from containers and packaging has brought heightened awareness of the health risks posed by extractables and leachables in... Read more
Tuesday the 12th November 2013
In the past two weeks both the FDA and the EMA have made moves to try to respond to growing concern over drug shortages. These measures are:
The FDA proposed a new rule that would require drug manufacturers to notify the FDA at least six months in advance of a possible interruption i... Read more
Friday the 8th November 2013
Two recent PDA events in Europe gave us the opportunity to spread the word about the training, auditing and consulting services that NSF Health Sciences offers in four local European languages, namely English, German, French and Italian.
The first event was the PDA Meeting on Pharmaceutical F... Read more
Wednesday the 6th November 2013
On the 4th November the EMA and FDA published a second Q&A paper resulting from their joint review of QbD submissions. This document is on the subject of ‘Design Space Verification’. A design space is established at early stages of product development, it is typically developed based on exper... Read more