Quality & compliance
In-house Quality and Regulatory oversight from supplier qualification and incoming material control through compounding, in-process checks, finished product testing, batch record review, release, stability and distribution. One team, in the building, for the whole lifecycle.
Regulatory
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.
We also identify the testing and documentation each project needs and coordinate with outside laboratories or international partners when a market calls for it.
The quality system
01
Suppliers are qualified before a material is ordered. Every incoming lot is received, sampled and tested against its specification, held in quarantine, and released by Quality before it can be weighed into a batch.
02
Compounding runs against an approved master batch record. In-process checks (pH, viscosity, appearance, fill weight, torque, codes) are recorded as the batch runs, and in-line cameras catch a fill or a label that drifts while the line is still running.
03
Finished product is tested in our own laboratory: micro, pH, viscosity, specific gravity and the appearance checks on the spec. The batch record is reviewed line by line and the batch is dispositioned by the Quality Unit before anything ships.
04
Stability at 40 °C and freeze-thaw, packaging compatibility and preservative efficacy before launch; ongoing stability and retained samples for the life of the product. A change to a formula, a material or a pack goes through change control, not around it.
05
Deviations, out-of-specification results and complaints each get an investigation with a root cause and a CAPA before the batch moves. Procedures are controlled documents, the team is trained against them, and internal audits check that the paper matches the floor.
06
An in-house regulatory group works alongside Quality from the brief onward, so the formula, the claims and the label are checked for the intended market before the first batch is made, not after.
OTC drug manufacturing controls
Sunscreen, anti-dandruff, acne and antiperspirant products are made under 21 CFR Parts 210 and 211 in the same building, under our FDA drug establishment registration. That is a separate set of controls, not general quality language, and it is why an OTC program carries extra testing and time.
Quality documentation
A brand evaluating a manufacturer wants to know what records exist and what it will be handed. This is the standard set; anything else your quality agreement asks for, ask.
Registrations and practice
FDA drug establishment
Registered
FDA cosmetic facility (MoCRA)
Registered
Drug products
21 CFR 210/211 cGMP
Cosmetic products
ISO 22716 practice
Audits
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.
Our most recent inspection observations, with our responses, are part of the quality pack for any brand that asks.
Ask for the quality packIn good company