Quality assurance
AZ Biopharm’s quality assurance system serves to ensure the quality expected by our customers and to enforce its own quality goals and regulatory requirements. The aim is to maintain and constantly improve the very good quality level. The AZ Biopharm works according to the principles of Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
- The GLP certificate includes the testing of the content and the physico-chemical properties of chemicals (category I) and bioanalytical determination of drugs and metabolites in biological matrix from non-clinical safety investigations (category VIII), certificate first issued in 2002, last certificate in December 2019
- The GMP certificate contains the permit according to § 13 AMG for chemical and physical quality control tests of human and veterinary medicinal products, certificate first issued in 2012, last certificate in April 2018
- Compliance with the GCP principles was confirmed by a joint audit by BfArM / AGES 2011.
All quality-relevant procedures and processes are regulated by a system of controlled documents in the form of:
- 80 standard operating instructions (SOPs),
- 300 test regulations and
- 50 special work instructions.
All quality assurance documents are checked at regular intervals and adapted to current requirements. Co-Workers are regularly trained on new and well-established documents. The QS system includes the following aspects, among others:
- Document management and archiving
- Personnel and training
- Cleaning and hygiene
- Self-inspections
- Quality risk management
- Qualification / validation of devices, processes and computer-based systems
- Change control, deviation, OOS and CAPA management
All specific responsibilities between the client and the contractor are defined and monitored in the form of quality agreements (VAV) or in the area of bioanalytics in study plans. The analysis results are recorded on controlled documentation and checked by the QS system. All devices and computerized systems are qualified and validated according to CFR 21 FDA part 11 and GAMP-5. Our well-functioning, in-house quality assurance basically builds on our qualified staff, who is improving through regular training and through membership and active participation in the German Society for Quality Management (DGQM).
In addition to testing drug products, starting materials, excipients and active pharmaceutical ingredients under GMP, AZ-Biopharm offers a QP service that can be booked for internal tests as well as for audits of external manufacturers and service providers
