Tuesday the 14th January 2014
Anybody that can answer YES to any of the following questions should attend one of our Human Error courses:
- Is re-training a common corrective action?
- Is revise the SOP a common CAPA?
- Are over 50% of your Deviations due to Human Error?
- Are your deviation re-occurrence rates really hig...
Sunday the 29th December 2013
On 28 November 2013 US President Obama signed the Drug Quality and Security Act into US law.
This Act addresses one of the omissions from FDASIA; the tracking of drug products in the USA. This new law immediately pre-empts all state laws concerning drug product track and trace, including Cali... Read more
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