The GMP requirements on the manufacture of active pharmaceutical
ingredients were harmonised not long ago. The interpretation of these
requirements is one of the top compliance topics both in the EU and with
That this topic plays an important role with FDA is proved by the fact
that Edwin Rivera's presentation slides on ICH Q7A have now been made
accessible to the public. On a total of 113 slides, Edwin Rivera has
taken up the individual chapters of ICH Q7A. This compilation is very
informative - not only for internal training purposes! Just click here
in order to be shown the slides.
In co-operation with APIC, a sector group of CEFIC, the association of
the chemical industry in Europe, we have just finalised 3 new programmes.
They will be of special interest to all those who aim at ICH Q7A
compliance. The parallel Education Courses:
take place in Lisbon, Portugal, on 27-29
January 2003. The speakers include 2 members of the ICH Q7A Expert
Working Group. The parallel events ensure that specific knowledge is
imparted to participants both from chemical and from biopharmaceutical API
Each of the seminars can be booked together with the directly following
auditor course. The number of participants of the Certified ICH Q7A Auditor
is limited - as it as for the other two Education Courses. If you are
interested in taking part, we recommend you to book early!