Quality Control
The testing and inspection activities performed on pharmaceutical products to verify they meet established specifications before release. For peptide drugs, QC includes identity testing, purity analysis, potency assays, sterility testing, endotoxin testing, and appearance inspection.
Technical Context
QC testing for peptide drugs: identity (confirmed by MS and/or AA analysis — ensuring the correct peptide is in the vial), purity (RP-HPLC — total purity and individual impurity levels), potency (bioassay or binding assay — confirming biological activity), sterility (USP <71> — 14-day incubation), endotoxin (LAL test — ensuring below pyrogenic threshold), water content (Karl Fischer titration — critical for lyophilised products), pH (for liquid formulations and reconstituted solutions), particulate matter (USP <788> — visible and sub-visible particles), container closure integrity (ensuring seal maintains sterility), appearance (visual inspection — colour, clarity, cake morphology), and peptide content (quantifying active ingredient per vial/dose). QC laboratories operate under cGMP with validated analytical methods, calibrated instruments, and qualified personnel. Out-of-specification (OOS) results trigger formal investigations per 21 CFR 211.192.