A
new article of interest:
A
new regulatory consideration has arisen that affects pharmaceutical facilities
of a certain vintage: the risks associated with the aging plant. In many more
established areas of the world, pharmaceutical facilities are passing various
time marks: thirty years, fifty years and even longer. As many pharmaceutical
companies seek to establish manufacturing facilities for new product lines in
emerging markets (China, Eastern Europe, Asia, for example) some of the more
established plants in regions like North America and Europe begin to look older
and possibly need more maintenance.
The
reference is:
Sandle,
T. (2016) Risk Consideration for Aging Pharmaceutical Facilities, Journal of Validation Technology, 22
(2): 11-20
Posted by Dr. Tim Sandle