Siegfried Annual Report 2009

Compliance
Introduction
Siegfried is committed to quality oriented management and
permanent improvement of all company processes and activities.
Our quality policy is an integral part of the corporate
policy.
Audits and inspections make the value of compliance/quality
evident. The results of customer audits and regulatory inspections,
in particular by the U.S. Food & Drug Administration
(FDA) and the Swiss Health Ministry (Swissmedic) confirm
our capabilities and are not only an indication of our
high quality standards, but also represent a solid competitive
advantage.
Policies
Siegfried has an overall quality management system
throughout our value chain. Based on the procedures set by
ISO 9001 (quality management) and ISO 14001 (environmental
management) www.iso.org, this system covers all
valid international guidelines:
– Current Good Manufacturing Practice (cGMP)
www.ema.europa.eu or www.fda.gov
– International Conference on Harmonization (ICH),
used to define standards by the pharmaceutical authorities
and industry associations in the U.S., Europe, and Japan
www.ich.org
– World Health Organization (WHO) www.who.int
The Compliance Board has a total of 24 members at the end
of 2009 and participants from executive management
(ExeCom). The Board meets every other month on the behalf
of the CEO and under the direction of the Chairman of
the Compliance Board to discuss quality issues at Siegfried.
Decisions on quality policy are made by the Compliance
Board, which also approves Siegfried Group policies.
While dealing mainly with quality issues, the Board also
influences areas of finance, safety, health and environment
(SHE), and pharmaceutical co-vigilance, and employee
conduct (Code of Conduct at www.siegfried.ch/en/siegfried/
company/code-of-conduct).
Inspections and audits
As is customary in the pharmaceutical industry, all Siegfried
sites are constantly monitored, through inspections (by regulatory
authorities), audits (by customers at Siegfried, or by
Siegfried at suppliers), and internal audits. Customer and
supplier audits are planned weeks and months in advance,
inspections and internal audits can occur without notice.
In general, regulatory inspections are carried out:
– In the U.S. by the Food and Drug Administration (FDA),
and by the Drug Enforcement Administration (DEA)
when narcotics are involved; for the first time the Japanese
Pharmaceuticals and Medical Devices Agency (PMDA)
carried out an inspection in 2009
– In Switzerland by Swissmedic, the Swiss Northeast Regional
Drug Inspection Agency (RHI) and the American FDA
– In Malta by the Medicines Authority Malta (MAM)
and the American FDA
– In Germany by the Federal Executive Committees
(Regierungspräsidien) and the American FDA
46 Sustainability Report