Siegfried Annual Report 2009

Since 2002, the FDA has issued clear “No Action Indicated”
approvals for our sites; all licenses have been approved or
renewed.
www.siegfried.ch/en/siegfried/compliance/inspection-history
Undergoing over 100 successful inspections and audits over
the past years gives Siegfried the chance to measure itself
against other company systems and regulatory demands –
and draw instructive conclusions about our application of
the guidelines. This confirms our quality system and is a persuasive
argument with our customers.
2010 is expected to be another intense year for inspections:
– For Siegfried Generics in Switzerland, possibly Swissmedic/
RHI; in Malta the Maltese health inspectors and perhaps
the American FDA
– For Siegfried Actives in the U.S. the FDA and DEA,
and possibly the Korean FDA
– For Siegfried Actives in Switzerland (in the active ingredients
area) the American FDA, and the Japanese Pharmaceuticals
and Medical Devices Agency (PMDA)
Customer audits will continue to take place frequently
in 2010.
Cooperation with public officials
Anti-counterfeit (product piracy): Siegfried works closely
with the American FDA to prevent product piracy and ensure
the safety of the end user. Siegfried provides material, certificates
and labels to enable the FDA to make comparisons
with potential counterfeit products.
Pharmaceutical co-vigilance (reporting system for
side effects):
The ongoing and systematic surveillance of drug safety is
done not only during clinical tests, but also after registration
to identify, evaluate, and understand any undesirable side effects,
as well as to implement the necessary risk minimizing
measures. The registration team within the Siegfried Generics
Division (in Munich, Germany) is responsible for these
issues and registered as the contact with the regulatory
authorities. Inquiries about undesirable side effects (ca.
1-2 annually) are usually made by our customers (customer
complaint) and not by the end user, who does not recognize
Siegfried as a producer. Siegfried’s pharmaceutical co-vigilance
system is being prepared and implemented for the
new inhalation technology product line.
Customer satisfaction
Siegfried is a service-oriented company that focuses on the
customer and cultivates close, long-term relationships. This is
why Siegfried has an established customer complaint system
(also stipulated in the pharmaceutical industry) to process
all inquiries and complaints. All external questions and complaints
are systematically registered, whether justified or not,
and evaluated. The type and number of complaints are systematically
recorded and the individual cases are evaluated
and discussed on a monthly basis by a quality-assurance
committee under the direction of subject matter experts
from Siegfried Actives and Siegfried Generics. If necessary,
changes are implemented. The Compliance Board is consulted
for critical or strategic questions. The results of the investigation,
or intermediate reports, are sent to the customer
within 30 days.
Sustainability Report
47