Sports nutrition manufacturing covers the dosage-form discipline for protein powders (whey concentrate/isolate/hydrolysate, casein, plant proteins), pre-workout formulations (caffeine 150-400 mg, beta-alanine 1.5-3.2 g, citrulline malate, creatine, taurine, tyrosine, theanine), essential and branched-chain amino acid blends, creatine monohydrate, intra-workout carbohydrate/electrolyte and post-workout recovery products. Protein controls include Kjeldahl/DUMAS nitrogen × 6.25 conversion, PDCAAS/DIAAS protein quality scoring, the protein-spiking adulteration screen via orthogonal HPLC amino acid profile verification, dispersibility (lecithin instantizing for cold-water mix), and flavour and high-intensity sweetener integration with palatability validation. Pre-workout controls centre on the banned-stimulant adulterant frontier — DMAA, DMHA, ephedrine, synephrine analogues, higenamine, methylsynephrine, halostachine, oxilofrine, hordenine, BMPEA, deterenol — with per-lot mass spec screen against the current FDA, WADA, NSF, BSCG and USADA panels and ingredient traceability supporting root cause if a banned stimulant is detected post-market. Caffeine source identification (anhydrous, guarana, coffee bean, yerba mate, green tea) for accurate label declaration. EAA/BCAA controls cover humidity envelope below 40% RH in process and packaging, oxygen scavenger and desiccant in primary pack, HPLC amino acid identity with ratio verification (BCAA mis-blend is a frequent failure), and fermentation-source allergen disclosure for vegan amino acids. Creatine monohydrate specifications cover Creapure or equivalent purity (≥99.95%) with creatinine, dicyandiamide and dihydrotriazine impurity ceilings, particle size for dispersibility, and avoidance of pre-dissolved RTD formats where creatine-to-creatinine degradation in solution undermines label dose. Sports-certification readiness layers lot-by-lot WADA-list testing (NSF Certified for Sport, Informed Sport, BSCG) onto the manufacturing baseline.

Regulatory anchors

21 CFR 111
USP <2750>
GOED Voluntary Monograph
WADA Prohibited List

Industries that live with this

Dietary Supplements

How V5 handles it

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

From the first pull to a signed CoA in your customer's hands.

One connected QC loop. The analyst runs the sample on the kiosk; the result lands on the chart; an out-of-spec opens its own investigation, spawns a CAPA, holds the batch and routes the disposition; the released lot's Certificate of Analysis is built from real values, signed under §11.50, and delivered to the customer portal with every view logged. No spreadsheets. No retyping. No quiet edits.

QC release — your reviewer sees only what failed.

By the time a batch reaches QC, every signed step has already rolled up. Your reviewer reviews-by-exception, signs, and releases — with the deviations and CAPAs already linked.