Quality Systems & GMP

Our team builds and optimizes GMP-compliant Quality Systems for supplement and wellness brands. We establish foundational QA/QC procedures to support sustainable growth.
From Master Manufacturing Records to Batch Production Records, we’ve got it covered. We assist with SOP development, deviation reporting, and CAPA programs. Our approach ensures audit-readiness and strong internal controls. Traceability and lot control? Built right into your workflows. We help bridge the gap between compliance theory and practical execution.

Whether you’re new to GMPs or scaling operations, we tailor solutions. Documentation templates and checklists are part of every engagement. We conduct gap assessments to identify weaknesses before the regulators do. Training, implementation, and continuous improvement support are included. Let us help you build a system that’s inspection-ready, every day.

Equipment and
Utensils

Equipment must be appropriately designed, properly maintained, and thoroughly cleaned. Calibration and maintenance logs must be retained.

Production and Process
Control System

Requires Master Manufacturing Records (MMRs) and Batch Production Records (BPRs). In-process specifications and controls must be implemented.

Holding and
Distribution

Storage must prevent contamination and product deterioration. Documented procedures for transportation must ensure product integrity and consistency.

Returned
Products

– Evaluate returned products to determine if they may be salvaged or destroyed.

– Prevent re-entry of unsafe products into the market.