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
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 2000)|
|Swissmedic||Mar 2000||GMP Certificate|
|Swissmedic||Nov 2001||GMP Certificate|
|Swissmedic||Nov 2002||GMP Certificate|
|Swissmedic||Dec 2002||GMP Certificate|
|FDA||Jun 2003||No Action Indicated|
|Swissmedic||Feb 2004||GMP Certificate|
|Swissmedic||Nov 2004||GMP Certificate|
|FDA||Aug 2006||No Action Indicated|
|Swissmedic||Nov 2006||GMP Certificate|
|Swissmedic||Dec 2006||GMP Certificate|
|Swissmedic||Feb 2007||GMP Certificate|
|Swissmedic||Jun 2007||GMP Certificate|
|FDA||Nov 2007||No Action Indicated|
|FDA||Jul 2008||No Action Indicated|
|Swissmedic||Apr 2009||GMP Certificate|
|Swissmedic||Aug 2009||GMP Certificate|
|Swissmedic||Oct 2009||GMP Certificate|
|FDA||Jul 2010||No Action Indicated|
|Sissmedic||Feb 2011||GMP Certificate|
|Korea FDA||Feb 2011||No Action Indicated|
|Swissmedic||Aug 2011||GMP Certificate|
|Swissmedic||Jan 2012||GMP Certificate|
|Swissmedic||Mar 2012||GMP Certificate|
|FDA||Jun 2012||Vol. Action Indicated|
|Swissmedic||Dec 2013||GMP Certificate|
|FDA||Feb 2014||No Action Indicated|
|Swissmedic||Aug 2014||GMP Certificate|
|Swissmedic||Dec 2014||New Equipment Approved|
|Swissmedic||Nov 2015||New Building Approved|
|ANVISA||Sep 2002||GMP Certificate|
|Customer Audits||approx. 50 audits/year|
|Inspections Pennsville, USA|
|FDA||Sep 2002||No Action Indicated|
|FDA||Jun 2003||No Action Indicated|
|FDA||Sep 2004||No Action Indicated|
|FDA||Jun 2006||No Action Indicated|
|FDA||Dec 2007||No Action Indicated|
|FDA||Dec 2008||No Action Indicated|
|FDA||May 2009||No Action Indicated|
|Japanese PMDA||Nov 2009||Accreditation Certificate|
|Korean FDA||Jun 2010||No Action Indicated|
|FDA||Mar 2011||No Action Indicated|
|FDA||Jan-Mar 2013||Vol. Action Indicated|
|FDA||May 2014||No Action Indicated|
|FDA||Mar 2016||No Action Indicated|
|Maltese Authorities||Nov 2006||GMP Certificate|
|Maltese Authorities||Apr 2008||GMP Certificate|
|Maltese Authorities||Mar 2010||GMP Certificate|
|FDA||Mar 2011||No Action Indicated|
|Maltese Authorities||Feb 2011||GMP Certificate|
|Maltese Authorities||Jan 2012||GMP Certificate|
|Maltese Authorities||Mar 2014||GMP Certificate|
|German Authority (GAA)||Nov 2014||License Granted|
|Swissmedic||Dec 2015||GMP Certificate|
|FDA||Apr 2016||No Action Indicated|