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The "GMP REPORT" is a publication series intended to facilitate the
implementation of current GMP guidelines in pharmaceutical operations.
Although there are no fixed publishing intervals or periods, two volumes
per year are issued as a rule.
So far, two reports have been published: The first issue covers "FDA
Requirements for cGMP Compliance". Twelve authors from the
pharmaceutical industry illustrate the efficient implementation of FDA's
cGMP requirements in routine operations.
The second issue "The Qualified Person", provides an overview of the
applicable European legislation framework and relevant guidelines. The
legal duties of the QP like batch certification are introduced and
discussed. The aspect of the QP's discretion in certifying a batch in
the case of deviations and OOS results, the possibility of delegating
tasks, the responsibilities within the quality system and also necessary
skills a QP needs for the daily business are reflected in various
articles.
Experts from international pharmaceutical companies as well as from the
national authorities share their experience on these issues and give
first-hand information of what is expected from QPs nowadays and in the
future.
On the website of the European Compliance Academy (ECA) under
Literature
you can find and order the issues published so far. The reports are
issued by the Editio Cantor Verlag (ECV) in Aulendorf, Germany. For
further information on the publishing house and on subscribing GMP
REPORT please visit www.ecv.de.
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