We are grateful for and very satisfied with the support provided by Rephine throughout the entire quality system design project and validation activities.
Client Testimonial
About this Case Study
Launching a new cannabis manufacturing operation is an exciting milestone for any young company. It is also a complex regulatory journey, particularly when GMP systems, facilities and validation activities need to be built from the ground up.
For this newly founded organisation, limited internal GMP experience meant external support was essential to design a compliant manufacturing plant, implement a workable Quality Management System and prepare for EU GMP inspection.
Rephine partnered closely with the client from the earliest stages of facility design through to qualification, validation and staff training. The focus was on creating a QMS that was practical, understandable and fit for a growing cannabis manufacturing environment, while embedding GMP expectations into daily operations.
By combining technical expertise with a supportive and hands on approach, Rephine helped the client move confidently from start up to EU GMP authorised manufacturer.
Key outcomes included:
- Authorisation to manufacture cannabis validation batches under EU GMP
- A fit for purpose QMS aligned with both GMP and GACP activities
- Operational readiness of a new GMP manufacturing plant and QC laboratory
- Improved regulatory confidence through training and internal audits
- GMP principles embedded across teams from the outset
Download the full case study to learn
- How new manufacturers can build GMP compliance step by step
- Why early GMP involvement is critical for facility design and validation
- How practical consultancy supports sustainable compliance from day one
Result
A GMP compliant cannabis manufacturing operation with strong foundations for future growth.
Download the Case Study
View other our other resources and company news
Article Veterinary GMP in Europe: New Dedicated Framework & VICH GL60 Guide
The EU veterinary sector enters a new era on 16 July 2026. Dedicated GMP regulations replace EudraLex Volume 4 for veterinary products. Learn what changes ...
Read More
Article MDR & IVDR Compliance: A Strategic Approach for MedTech
Regulatory compliance under MDR and IVDR has moved beyond documentation to become a strategic discipline that shapes every stage of a medical device's lifecycle. This ...
Read More
Medical Device MDR & IVDR Compliance as a Business Outcome
Rephine's 2026 White Paper on MDR & IVDR compliance: strategic guidance for MedTech companies to reduce regulatory risk, avoid delays, and reach the EU market ...
Read More
Case Study Full GMP Internal Audit Program Executed On Time
A pharmaceutical manufacturer needed to complete their annual EU GMP internal audit cycle across 11 departments, without the internal capacity to do it. See how ...
Read More
QMS From local to global: scaling your QMS for UK–EU operations
Learn how UK life sciences companies can scale their quality management system into EU markets without losing compliance, visibility, or operational control.
Read More
QMS Scale Your Quality System from UK to EU Without Losing Control
Learn how UK life sciences companies can scale their quality management system into EU markets without losing compliance, visibility, or operational control.
Read More
Article Pharmaceutical Equipment Qualification & Control System Validation
Qualifying process equipment and control systems is fundamental to GMP compliance. This guide breaks down how to define user requirements, apply risk-based testing, and maintain ...
Read More
Case Study GMP Consultancy for a New Cannabis Manufacturing Plant
A start up cannabis manufacturer partnered with Rephine to design a GMP compliant facility, implement a practical Quality Management System and prepare for EU GMP ...
Read More
Article How an Internal Services Audit Can Maximise Your Regulatory Compliance
Internal services audits play a critical role in maintaining GMP compliance and driving continuous improvement. This article explores how structured gap assessments, internal audits and ...
Read More
