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
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