QMS Implementation for Cannabis Manufacturer

Rephine’s support allowed us to build a compliant quality system from the ground up. Their expertise in QMS design and validation gave us the structure and confidence to move towards GMP authorisation as a new company

Client Testimonial

About this Case Study

A newly established cannabis API manufacturer needed to rapidly design and implement a compliant Quality Management System (QMS) to secure GMP authorisation and begin commercial operations.

With limited in-house GMP expertise, the company required support in building regulatory-ready systems and preparing their facility for inspection. Rephine partnered with the client over a 12–18 month programme, delivering a tailored QMS, qualification and validation processes, and guidance on regulatory documentation. Alongside system implementation, Rephine helped upskill internal teams, laying the foundation for sustainable compliance and future audits.

Key outcomes included:

Development and deployment of a fit-for-purpose GMP-compliant QMS
Successful implementation of qualification and validation processes
Improved site readiness for GMP authorisation and inspection
Enhanced GMP knowledge and capability across internal teams
Reduced compliance risks through structured processes

✅ Download the full case study to discover:

How Rephine supported a new manufacturer in building compliance from the ground up
The QMS design and validation strategies enabling GMP readiness
How regulatory preparation accelerated progress towards authorisation

Result: A compliant, inspection-ready quality system supporting the company’s transition to commercial production.