Four Pillars of Siegfried Compliance

Quality Assurance

• Implementation of the quality policies of Siegfried regarding the cGMP, ICH, EU-GMP, 21 CFR, ISO 9001:2000 and ISO 14001 regulations as well as internal quality requirements
• Assessment and approval of master batch records, testing methods and specifications
• Assessment and approval of their change control procedures
• Registration and assessment of investigation reports about raw material and internal complaints, deviations from analytical procedures and process deviations
• Scrutiny of the complete batch documentation
• Release of specified intermediates, active pharmaceutical ingredients as well as clinical trial material and final dosage forms
• Treatment of quality related customer inquiries and investigation of customer complaints
• Supervision of the current product quality through the preparation of the Annual Product Reviews and Product Quality Reviews
• Supervision of the chemical and pharmaceutical technical part of the registration dossiers
• Supervision of the organisation regarding the advisability and the improvement of quality
• Supervision of qualification and validation activities

Validation and Qualification

• Equipment qualification
• Process validation
• Cleaning validation
• Computer system validation

Quality Control

• Testing of APIs, intermediates, finished dosage forms, raw materials and packaging materials for chemical and pharmaceutical production
• Chromatography (HPLC and GC), spectroscopy, titration and wet chemistry
• Method transfers and validation, process validation samples, purity profiles and stability testing of APIs and intermediates

Quality Management

• Contracts
  - Describe responsibilities of quality, regulatory and production personnel
  - Guarantee consistently high performance of all our products
• GMP Training
  - Organized and performed by the Quality Management department
  - Internal courses to maintain a high level of GMP awareness
• Internal/External audits
  - Monitor the implementation and respect of cGMP within Siegfried
  - Ensure that requirements are met by vendors and subcontractors
• Inspections/Customer audits
  - Verification of compliance by regulatory authorities
  - About 30 customer audits per year for evaluation purposes
• Document Management/Archiving
  - Documentation system according to GMP requirements (ICH, EU-GMP, FDA) and ISO 9001:2000