DNA barcoding is the molecular identity method that amplifies and sequences a short standard locus (ITS2, rbcL, matK, psbA-trnH) and matches it to a reference library to confirm botanical species. It is powerful for raw whole or coarsely milled botanicals (NY AG 2015 herbal-supplement findings made it famous), but it does not work on extracts where DNA is degraded or removed — there it must be paired with HPTLC or marker-compound HPLC for a defensible 111.75 identity record.

Regulatory anchors

21 CFR 111.75

How V5 handles it

QMS — quality records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

DNA barcoding for botanicals

Next step

DNA barcoding for botanicals

Next step