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

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.

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

Quality Management

Contracts

The quality contracts specify the areas of responsibility of quality-relevant activities between the involved parties. 

GMP training 
  • GMP training is organized and carried out by the Quality Management department.
  • Internal courses are offered for maintaining a strong and solid GMP awareness.
Internal/External Audits

Internal audits monitor the implementation and observance of cGMP guidelines and Siegfried’s specific requirements within the corporate group. These audits ensure that Siegfried’s cGMP requirements are fulfilled by both suppliers and contract manufacturers.

Inspections/Customer Audits
  • Inspections and audits by authorities and customers serve to verify compliance with guidelines and are supported by Quality Management.
  • Approximately 50 customer audits and inspections of our systems are conducted every year. 

Document Management/Archiving

Siegfried’s documentation system is based on GMP guidelines (ICH, EU-GMP, FDA) and ISO 9001:2000.

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