Inspected by camera, not by eye
Vision systems run on the line rather than at the end of it, so a fill weight, a cap or a label that drifts is caught while the batch is still running, not in a QC sample after the run is off the floor.
Quality & compliance
A regulatory team in the building, and a line that watches itself.
Two things decide whether a program ships on time: whether somebody can answer the regulatory question the week it is asked, and whether the floor catches a problem while the batch is still running. Both are in-house here.
Regulatory
Tell us where you want to sell.
Our regulatory group works in the building rather than on retainer, with experience across multiple countries and standards. Tell us the markets you are aiming at and we will tell you what each one requires (ingredient restrictions, claim limits, labeling, the registration or notification that has to be filed) and then put the file together with you.
That includes the questions that decide a formula before it is written: whether an active is permitted where you are selling, at what percentage, and what you are allowed to say about it. Finding that out at the brief is cheap. Finding it out at the border is not.
The floor
Automated, and watched.
Monitored around the clock
The floor is instrumented and watched 24/7. The point of continuous monitoring is not the record it produces; it is seeing a process move before it moves out of specification.
A batch record that follows the unit
Every unit is traceable to its batch, its incoming lots and the checks run on it. Every failed result gets an investigation before the batch moves.
Registrations
FDA drug establishment
Registered
FDA cosmetic facility (MoCRA)
Registered
cGMP
21 CFR 210/211 for drug; ISO 22716 practice for cosmetic
California
Licensed manufacturing facility, Chatsworth
Audits
Come and look.
We host customer audits and we do not schedule them for a quiet week. Bring your quality consultant, walk the line, pull a batch record at random and read it. If you need a quality agreement, we will sign yours rather than insisting on ours.
For the brands that need it we provide: master batch records, certificates of analysis per lot, stability data, preservative efficacy results, allergen and origin statements, and our most recent inspection observations with responses.
Ask for the quality pack