Compliance is our commitment. Expect more with Siegfried as your preferred partner as we are committed to continuous accountable improvement and quality-centered management of all company processes and activities. The quality policy within Siegfried forms an integral part of our overall company policy.
The values our customers can expect from Siegfried’s Quality Policy include:
Siegfried maintains a compliance board with highly qualified senior management for complete global compliance and harmonization along our value chain of drug substance and drug product. Employing an integrated quality management system further demonstrates and supports the strong commitment we have to our internal and external customers in order that we have complete quality responsiveness. Having an outstanding long term compliance record illustrates the core competency and assured value our customers gain from a partnership with Siegfried.
By implementing an integrated quality management system we give consideration to the quality concerns of our internal and external customers. Our established compliance record reflects our core competencies as well as the strong values our customers benefit from in a partnership with Siegfried.
Commitment to quality is the backbone to Siegfried’s corporate policy. Hence, the management is devoted to continuously improve all processes and activities across the company.
Open and continuous communication with the authorities, customers and suppliers is essential for a well-functioning cooperation. Results of customer audits and of inspections by the authorities make Siegfried’s performance and capabilities transparent. As is typical in the pharmaceutical industry, all of Siegfried’s sites are being monitored constantly. A difference is made between inspections (authorities), audits (by customers or by Siegfried at suppliers) and internal audits.
As a rule, inspections by the authorities are carried out
Quality Assurance
Maintaining sustainability standards in the delivery chain represents an elementary value adding factor and, at the same time, an important lever in the implementation of our “Code of Business Conduct” and for risk minimization. Securing sustainability along the entire delivery chain requires joint efforts and orientation toward long-term and value-oriented action. We are convinced that sustainability in the delivery chain can be obtained only by means of unambiguous rules concerning choice and qualification of our suppliers and in close cooperation with established suppliers. We consider the cooperation with our suppliers to be an opportunity to integrate sustainability into the entire value-added process. Our suppliers play a decisive part in our sustainability performance, and that is why cooperation with them has to be based on principles that we share.
Audits are carried out periodically at the suppliers’ locations. In terms of these audits, Siegfried monitors the social and ecological effects along the value-added chain and identifies potential risks, which Siegfried addresses and from which measures are deduced. Non-compliance with minimum standards will result in a delivery block or change of supplier.
In distribution, our aim is to offer our customers high-quality products and services and build up long-term relationships with them. Distribution at Siegfried is strictly regulated and subject to relevant laws. The group-wide Code of Conduct makes no allowance for violation of the law and requires strict adherence to anti-corruption guidelines and antitrust legislation.
Often, raw materials, pharmaceutical auxiliaries, packaging material, API components and occasionally APIs are purchased by manufacturers and suppliers abroad to be used by Siegfried. In such cases, Siegfried is responsible for qualifying these manufacturers and suppliers, and we therefore make use of an audit system to carry out qualification in accordance with applicable quality standards.
Triggered by a rising quality awareness, and consequently higher demands made on quality on the customer side, the number of inspections and certificates / statements required from the pharmaceutical industry is growing steadily, often due to accidents, counterfeiting and sub-standard mixtures. Today, in addition to analysis certificates, which have been required for a long time, concerning appearance, purity, content, physical characteristics and GMP-conform production of our products, customers and regulatory authorities today require data and certificates concerning genotoxic impurities, freedom of heparin adulteration, freedom of hidden genetically modified parts including TSE / BSE, melamine, benzene, etc. Siegfried works in close cooperation with the US-FDA concerning product piracy in order to combat counterfeiting and to safeguard consumer safety.
Good Distribution Practice (GDP) is a topic that has gained significance since the introduction of new international guidelines in 2013. The aim is to ensure that the entire supply chain of materials from manufacturers / suppliers to Siegfried, and from Siegfried to our customers is safeguarded against incorrect transportation and storage conditions as well as fraudulent attempts at counterfeiting.
Inspections Zofingen, Switzerland (since 2010) | ||
---|---|---|
FDA | Jun 2019 | No Action Indicated |
Swissmedic | Oct 2018 | New Building Approved |
Swissmedic | Jun 2017 | GMP Certificate |
FDA | Jan 2017 | Observations (closed) |
Japan’s PMDA | Jun 2016 | No Action Indicated |
Swissmedic | Nov 2015 | New Building Approved |
Swissmedic | Dec 2014 | New Equipment Approved |
Swissmedic | Aug 2014 | GMP Certificate |
FDA | Feb 2014 | No Action Indicated |
Swissmedic | Dec 2013 | GMP Certificate |
Japan’s PMDA | Jun 2012 | No Action Indicated |
FDA | Jun 2012 | Observations (closed) |
Swissmedic | Mar 2012 | GMP Certificate |
Swissmedic | Jan 2012 | GMP Certificate |
Swissmedic | Aug 2011 | GMP Certificate |
Korean FDA | Feb 2011 | No Action Indicated |
Swissmedic | Feb 2011 | GMP Certificate |
FDA | Jul 2010 | No Action Indicated |
Inspections Pennsville, USA | ||
---|---|---|
FDA | Dec 2018 | Observations |
FDA | Apr 2018 | No Action Indicated |
FDA | Mar 2016 | No Action Indicated |
FDA | May 2014 | No Action Indicated |
FDA | Mar 2013 | No Action Indicated |
FDA | Jan-Feb 2013 | Observations (closed) |
FDA | Mar 2011 | No Action Indicated |
Korean FDA | Jun 2010 | No Action Indicated |
Inspections Malta | ||
---|---|---|
MMA | Aug 2019 | GMP Certificate |
FDA | May-Jun 2018 | No Action Indicated |
MAM | Nov 2016 | GMP Certificate US-FDA and MHRA |
MAM | Mar 2014 | GMP Certificate |
MAM | Feb 2012 | GMP Certificate |
MAM | Feb 2011 | GMP Certificate |
FDA | Mar 2011 | No Action Indicated |
MAM | Mar 2010 | GMP Certificate |
Inspections Irvine, USA | ||
---|---|---|
FDA | Feb 2019 | Observations (closed) |
FDA | Apr-May 2017 | Observations |
FDA | Aug 2015 | No Action Indicated |
TUV (ISO) | Jul 2015 | No Major Observations |
MHRA | Oct 2014 | No Major Observations |
FDA | Jul 2014 | No Action Indicated |
TUV (ISO) | Jun 2014 | No Major Observations |
FDA | Jul-Aug 2013 | Observations (closed) |
TUV / LGA (ISO) | Jun 2013 | No Major Observations |
MHRA | Jul 2012 | No Major Observations |
LGA (ISO) | Jun 2012 | No Major Observations |
FDA | Apr 2012 | Observations (closed) |
LGA (ISO) | Jul 2011 | No Major Observations |
FDA | Mar 2011 | Observations (closed) |
MHRA | Dec 2010 | No Major Observations |
FDA | Aug-Sep 2010 | Observations (closed) |
LGA (ISO) | Jun 2010 | No Major Observations |
Inspections Minden, Germany | ||
---|---|---|
FDA | Mar 2019 | Observations (closed) |
German Health Authority | Mar 2017 | No Action Indicated |
FDA | Feb 2017 | No Action Indicated |
FDA | Oct 2014 | Observations (closed) |
German Health Authority | May 2014 | No Action Indicated |
FDA | Feb 2011 | Observations (closed) |
German Health Authority | Feb 2011 | Observations (closed) |
Korean FDA | Oct 2010 | No Action Indicated |
Inspections Hameln, Germany | ||
---|---|---|
GAA | Dec 2018 | GMP Certificate |
FDA | Apr 2018 | Observations (closed) |
GAA | Oct 2016 | GMP Certificate |
FDA | Jun 2016 | Observations (closed) |
FDA | Jul 2014 | Observations (closed) |
GAA | Jun 2014 | GMP Certificate |
GAA | May 2014 | GMP Certificate |
FDA | Jun 2012 | Observations (closed) |
GAA | Mar 2012 | GMP Certificate |
GAA | Oct 2011 | GMP Certificate |
GAA | Jan 2010 | GMP Certificate |
Passed Inspections by authorities from | ||
---|---|---|
ANVISA | Mar 2018 | |
FDA Ghana | Feb 2017 | |
Ministry of Health of Belarus | Feb 2017 | |
Ministry of Health Kenya | Mar 2017 / Mar 2014 / Apr 2011 | |
Russian Authority | Sep 2016 | |
National Drug Authority Uganda | Apr 2016 | |
Turkish Authority | Mar 2015 / Jul 2012 | |
Korea FDA | Feb 2012 | |
ANVISA | Aug 2011 | |
TFDA, Department of Health, Executive Yuan, Taiwan | Aug 2010 |
Inspections Evionnaz, Switzerland | ||
---|---|---|
FDA | Jun 2019 | No Action Indicated |
Swissmedic | Jun 2018 | GMP Certificate |
FDA | Mar 2016 | No Action Indicated |
Swissmedic | Nov-Dec 2015 | GMP Certificate |
FDA | Nov 2013 | No Action Indicated |
Swissmedic | Jun 2012 | GMP Certificate |
FDA | Aug-Sep 2011 | Observations (closed) |
Inspections St. Vulbas, France | ||
---|---|---|
FDA | Jun 2018 | Observations |
ANSM | Oct 2016 | GMP Certificate |
FDA | Sep 2016 | Observations (closed) |
FDA | Dec 2013 | Observations (closed) |
ANSM | Sep 2013 | GMP Certificate |
ANSM | Jun 2011 | GMP Certificate |
FDA | Jan 2010 | Observations (closed) |
Inspections in Nantong, China | ||
---|---|---|
FDA | Aug 2019 | No Action Indicated |