Quality Management System | From Research to GMP Quality

Good Manufacturing Practices for GMP Peptides & Dyes

AnaSpec manufactures GMP peptides & Dyes according to ISO9001 and parts of 21 CFR 210 and 211 tailored to the customers’ product intended use, with all downstream processes occurring in our ISO 7 Classified GMP cleanrooms.

Quality Control for GMP

GMP peptide for IVD

AnaSpec manufactures GMP peptides & dyes in support of in vitro diagnostic and related applications. The IVD medical device industry is regulated by FDA cGMP/QSR (21 CFR Part 820), EU IVD Directive 98/79 EEC and EU 2017/746 Regulation.  AnaSpec quality system is compliant to most of the applicable quality system requirements of these regulations.