Quality Compliance

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:

  • Commitment of Siegfried management and employees to strive for full compliance according to current cGMP standards.
  • The assurance that all procedures at Siegfried are in compliance with the requirements of the authorities and the needs of our customers.
  • Continuous improvement and control by internal and external (customers and authorities) audits.

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.

Siegfried Compliance-Model

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

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.

Inspections and Audits

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

  • in the USA by the Food and Drug Administration (US-FDA) and for narcotics by the Drug Enforcement Administration (DEA)
  • in Switzerland by Swissmedic which in turn delegates the inspection to the“Regionales Heilmittelinspektorat Nordwestschweiz” (RHI) and by the US-FDA
  • in Malta by the Medicines Authority Malta (MAM) and the US-FDA
  • in Germany by the regional councils and the US-FDA
  • in France by the national French authority (ANSM) and the US-FDA

Quality Assurance 

  • Ensuring Siegfried’s quality policy with respect to guidelines in the areas of cGMP, ICH, EU-GMP, 21 CFR, ISO 9001:2000 and ISO 14001, as well as internal quality requirements
  • Testing and approval of manufacturing guidelines, test methods and specifications
  • Testing and approval of changes
  • Registration and evaluation of examination reports for internal complaints, as well as any deviations in GMP-related tasks and processes
  • Examination of the complete batch documentation
  • Release of interim products, pharmaceutical actives, clinical trial materials and dosage forms
  • Processing of quality-related customer requests and examining customer complaints
  • Periodic monitoring of product quality through the creation of annual product and quality reports
  • Supervision of the technical aspects of chemical and pharmaceutical registration documents
  • Organization-wide monitoring with respect to quality improvements

Sustainability in the Supply Chain

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.

Cooperation with Suppliers

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.

Distribution

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.

Qualification of Suppliers and Service Providers

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.

Quality Requirements and Quality Certificates

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)

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.

Compliance Track Record

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
Other
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
Inspections Malta
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
Inspections Hameln
German Authority (GAA)  Nov 2014 License Granted
Inspections Evionnaz
Swissmedic  Dec 2015 GMP Certificate
FDA Apr 2016 No Action Indicated
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Siegfried AG
Untere Bruehlstrasse 4
CH-4800 Zofingen

Phone: +41 62 746 1111
Fax: +41 62 746 1202
info@siegfried.ch