QA for GMP Products
AnaSpec’s Quality Assurance department rigorously monitors the manufacturing of the GMP products that we produce to 21 CFR 210 and 211 and ICH Q7 guidelines.
Quality Management System
AnaSpec maintains a Quality Management System that ensures every employee operates within the guidelines of our standard operating procedures and fulfills our global quality policy.
Our GMP upstream rooms are dedicated to GMP synthesis and cleavage processes. The GMP ISO 7 classified (10,000) downstream cleanroom areas are dedicated to purification, lyophilization and packaging operations. The GMP upstream and downstream areas are completely segregated with limited access.