Siegfried – Committed to Quality

Commitment to quality is the backbone to Siegfried’s corporate policy. Management leads by example by pursuing continuous improvement of all processes and activities across the company.

• 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

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.