having worked many years in the
pharmaceutical industry myself I've seen
all of this firsthand these are
questions that face everybody take a
pharmaceutical company today's biopharm
industry is a complex world the
pharmaceuticals are complex and no less
complex of the processes that
manufacture them unfortunately the many
guidelines and standards that regulate
the industry don't make things any
easier even experienced engineers have
difficulty understanding the various GMPs
the language is formal and
vague and the way the GMPs are
worded can be downright confusing it's
no surprise that for every GMP there are
many interpretations so what do the
GMP's really say in short they don't
provide any specific answers as Per-Åke Ohlsson
head of Alfa Laval market unit farm
equipment explains they contain general
principles that must be understood and
applied correctly to find the solution
for a given situation the sole purpose
of the GMPs is to make processes
safer and better but the GMPs
complexity and the difficulty of
designing biopharm production systems
means some of the basic truths get lost
when the guidelines are not fully
understood people keep doing what
they've always done and that may or may
not be what's best Per-Åke together
with his colleagues at Alfa Laval would
like to bring some clarity into biopharm
production by highlighting the
principles behind the GMPs on the
biopharm pages of the Alfa Laval
website they've boiled down the GMPs for
equipment into manageable concepts
allowing you to look at the real issues
what people in the industry want to know
is how all these little things affect
the big picture what does a well-done
mean for contamination risk for example
how can internal equipment design
facilitate cleaning and what should be
expected in spare part documentation the
GMPs have implications but they seldom
provide straight answers help is
available on the biopharm pages of Alfa
Laval calm within the key areas of
equipment performance documentation and
hygiene
Per-Åke and his colleagues provide
insights into biopharm concerns you'll
learn about potential equipment pitfalls
and how to avoid them and about saving
time and money in the process we've even
included information about how Alfa
Laval approaches these issues with
examples of how we incorporate the GMP
principles into our own products in
addition there are downloadable white
papers for those who want great the
depth see for yourself by exploring the
biopharm pages at Alfa Laval calm and be
sure to check back for new developments
if by chance you can't find what you're
looking for Per-Åke would be there to
help you out these are the same issues I
discussed select use some by phone
conferences and the website is a perfect
forum to continue the dialogue my team
and I are always on hand to help you
find solutions and defined our contact
information on the website
you