Quality Compliance

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.