Quality Management System
From Research to GMP Quality
Quality is a fundamental core value of our business and culture. We consistently strive for excellence in the products and services that we offer with honesty and transparency. Accordingly, AnaSpec maintains a Quality Management System (QMS) that ensures every employee operates within the guidelines of our standard operating procedures and fulfills our global quality policy. Stringent manufacturing controls as well as our QA and QC programs are integral to our QMS system.
ISO 9001 certification
Our Quality Management System is ISO 9001:2015 certified under certificate number 09.357.1.
This certification applies to the following activities: “Manufacturer/re-packer and supplier of peptides, antibodies, assay kits, synthesis resins, amino acids, dyes, reagents for life sciences research and a distributor of qPCR reagents.”
ISO 7 Certified Cleanrooms
Our state-of-the-art highly controlled GMP cleanroom areas for downstream processing are classified as ISO 7 (class 10,000). Complete segregation between the upstream process (synthesis and cleavage) and the downstream processes (purification, lyophilization and packaging) mitigates the risk of cross-contamination.
GMP peptide applications
AnaSpec GMP peptides may be further processed by the customer and used for such applications as NeoAntigens for Ex Vivo Cell Therapies, Cosmetic ingredients, Biopharmaceutical processing starting materials, QC Standards, and for Pre-clinical animal studies.