All GMP manufacturing operations are performed in a campaign fashion with initial cleanroom line clearance release by Quality Assurance personnel that ensures there is no risk of cross-contamination.
Comprehensive Batch records
All GMP manufacturing operations are captured in QA issued robust Batch Production Records. Every GMP peptide includes a comprehensive list of attributes as product specification sheet with pre-established acceptance criteria that guarantees high quality as per customer specification.
API drug substance GMP peptides
AnaSpec manufactures GMP grade peptides for use in early Phase clinical trials under our comprehensive quality management system compliant with 21 CFR 210 and 211 and ICH Q7 guidelines. These peptides can also be used for Emergency (EIND) use.
Diagnostic Use Peptides & Dyes
AnaSpec manufactures GMP peptides for use as analyte specific reagents (ASR’s) in in-vitro diagnostic testing 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.
Although AnaSpec does not manufacture medical devices, we are compliant to most of the applicable quality systems required for their manufacture.
Non-clinical Use GMP peptides
Our GMP peptides can also be used for non-clinical applications including Cosmetic ingredients, Biopharmaceutical in-process materials, QC Standards, Pre-clinical animal studies, and more.