Quality Assurance (QA) for GMP
AnaSpec’s GMP manufacturing is overseen by our independent QA department, that ensures GMP operations adhere to our robust Quality Management System (QMS). AnaSpec’s QA department monitors GMP manufacturing as per parts of 21 CFR 210, 211 applicable for products intended use and per part 820 of 21 CFR for Diagnostic applications.
Production in Cleanroom
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 a QA released comprehensive Batch Production Records. Every GMP peptide includes a QA released product specification sheet with pre-established acceptance criteria that guarantees high quality as per customer specification.
Diagnostic Use Peptides
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.
Critical Raw Materials
AnaSpec produces GMP raw material peptides that can be further processed by the customer for such applications as NeoAntigen/Ex Vivo Cell Therapies, Cosmetic ingredients, Biopharmaceutical processing starting materials, QC Standards, and Pre-clinical animal studies.