AZ Biopharm works according to the principles of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). All processes within the company are underpinned by a system of standard operating procedures (SOPs), test specifications and special work instructions.
Our efficient, in-house quality assurance is due to our qualified employees who take part in regular training in order to try to improve constantly. OOS and CAPA management as well as equipment qualifications are also essential elements of our quality management system. The regular updating of the quality assurance documents and monitored documentation of the analysis results complete our QA system.
Internal and external inspections and audits confirm the high degree of compliance of the laboratory operations with the GLP and GMP principles.
A Site Master File pursuant to EU Regulations is available on request.