SERVICES
Operations and Quality Systems
Build the systems that let you grow volume, SKUs and partners without losing control of quality.
Quality systems sized for your stage
Quality management system build-out
A right-sized QMS for where you are now, from document control and change control to complaints, returns and corrective actions.
SOPs and records
Standard operating procedures, master manufacturing records and batch production records written for how your operation actually runs.
Specifications and testing programs
Component, in-process and finished product specifications, with testing plans that meet 21 CFR Part 111.
Supplier and manufacturer qualification
Supplier approval programs, quality agreements and audits of the partners you depend on.
Environmental monitoring
Microbial monitoring of air, surfaces and personnel, a frequent finding in third-party cGMP audits.
Operations and workflow reviews
Finding the process and workflow bottlenecks that quietly hold growth back.
Fractional QA
Senior quality-control oversight on a part-time basis, including batch record review and release support, until a full-time hire makes sense.
Systems on paper do not pass audits. People do.
A quality system works when leadership supports it, production owns it, QA enforces it and training never stops. We work with all four groups so the system holds up on the floor and keeps working after the engagement ends.
Brand owners have quality obligations too
Companies that sell supplements made by a contract manufacturer still carry cGMP responsibilities under 21 CFR Part 111, including specifications, product review and complaint handling. We help brand owners build the lean quality system that responsibility requires.
Ready to strengthen your quality system?
Start with a gap assessment and a clear, prioritized plan.
(631) 901-5164 | info@nutrition50.com