RX Extraction’s Quality Management System supports the technical activities described across this site, ensuring that cannabinoid active substances are manufactured consistently, safely, and in compliance with applicable UK GMP requirements.

Quality oversight is integrated into:

  • Process design
  • Manufacturing execution
  • Batch documentation and release
  • Continuous improvement

Our focus is not compliance in isolation, but compliant manufacture that works in practice.

How Quality Is Applied in Practice

Quality at RX Extraction is embedded into each stage of the manufacturing lifecycle, from receipt of starting material through to release of cannabinoid active substances.

This includes:

  • Qualification and assessment of incoming plant source material
  • Controlled execution of extraction, purification and crystallisation processes
  • In-process controls to monitor critical manufacturing parameters
  • Review and approval of batch documentation prior to release

This approach ensures that quality is an active part of manufacturing operations, not a separate or retrospective function.

Starting Material Control & Assessment

All incoming starting materials are subject to defined assessment and acceptance criteria prior to use in manufacturing.

Where plant material is not suitable for finished medicinal product presentation, but remains appropriate for active substance manufacture, suitability is formally evaluated and documented within the Quality Management System prior to processing.

Material status, traceability and disposition are controlled in accordance with GMP principles to ensure that only approved materials enter manufacturing processes.

Documentation & Traceability

RX Extraction maintains full end-to-end traceability across its manufacturing operations, including:

  • Receipt and status control of materials
  • Batch manufacturing and processing records
  • Deviation, change control and CAPA management
  • Retained documentation to support audit and inspection

All records are generated, reviewed and retained in accordance with data integrity principles and applicable regulatory expectations.

People, Training & Competency

All personnel involved in GMP activities are trained to an appropriate level for their role and operate in accordance with approved procedures.

Training and competency management are supported by:

  • Role-specific competency requirements
  • Initial and ongoing GMP training
  • Documented training records and periodic review

This ensures that manufacturing activities are carried out consistently and sustainably by qualified personnel.

Quality Oversight & Continuous Improvement

Quality performance is monitored and reviewed through:

  • Internal audits
  • Management review processes
  • Trending and evaluation of deviations, CAPA and quality metrics

This structured oversight supports continuous improvement and ensures that manufacturing processes remain effective, compliant, and aligned with regulatory expectations.

Future Capability

RX Extraction’s quality systems are designed to support both current active substance manufacturing activities and planned future capabilities, including Specials packing, subject to regulatory approval.