AZ Biopharm is committed to ensuring the highest quality standards. All of the company’s processes are based on a system of standard operating procedures (SOPs), test specifications and special operating procedures. The methods used are validated in a manner specific to the individual product. Regular checks and training guarantee the sustainability of our quality assurance.
For marketing authorisation dossiers and product specifications, all analyses are carried out in accordance with the applicable GLP guidelines. Our quality assurance unit monitors all studies carried out, from the planning stage right through implementation of tests and up to the archiving stage, in line with a quality assurance programme.
- AZ Biopharm is certified as a testing facility by the Berlin State Office for Industrial Safety, Health Protection and Technical Safety. Our GLP certificate covers test categories I and VIII.
- GLP compliance statement, section 19 b paragraph 1 of the German Chemicals Act (2003 & 2009)
- Certificate of GMP compliance for a Pharmaceutical Laboratory Accounting to § 13 (1) and § 72 of the German Drug Law.
Human medicines Veterinary medicines
permitted activities
quality control
Chemical / Physical
The permit includes the testing of drugs and medicines
- All equipment and storage facilities for test samples are qualified/validated. Storage conditions are subject to constant monitoring and recording.