http://www.labcompliance.com/news/2007/09_september_news.aspx#06


September 27, 2007

PIC/S Releases New Versions of GMP Guides
On September 1, 2007, the Pharmaceutical Inspection Convention Scheme
(PIC/S) released new guides for GMP. They contents and structure are more
close to the corresponding EU guides. However, there are also still some
differences. For example, the Position of a Qualified Person as defined in
the EU guide is still called Authorized Person. The new guides can be
downloaded from the PIC/S website:

Guide to Good Manufacturing Practice for Medicinal Products (Part I)

Guide to Good Manufacturing Practice for Medicinal Products (Part II)

Guide to Good Manufacturing Practice for Medicinal Products (Annexxes)

September 17 2007
Recent FDA Inspection Findings Related to Part 11 and Computer Systems
About two years after FDA's release of 21 CFR Part 11 the FDA started to
enforce the regulation. This was in 1999. Between 1999 and 2002 the FDA
reported many deviations to the regulations in 483's, EIR's and Warning
Letters but also through conference presentations of FDA officials. With the
promotion of the the new approach in 2003 the FDA stopped enforcing Part 11
and requirements for computer systems but resumed in 2004 and thereafter
with highest density in 2006 and 2007. Most deviations have not been
referenced directly to Part 11 but to predicate rule requirements. In some
cases the FDA also gave advice to specific questions related to Part 11.
Labcompliance has published excerpts of 16 FDA inspection reports (483's,
warning letters, EIR's) from inspections between 2004 and 2007.
Labcompliance has also developed a Part 11 Compliance Package that helps to
avoid deviations reports according to current and future Part 11
requirements.