GMP Services
QMS Development
Develop a comprehensive pharmaceutical Quality Management System (QMS) that establishes clear responsibilities, controlled processes and documented evidence of compliance. We build practical quality systems aligned with EU GMP requirements and designed to support the day-to-day operation and continual improvement of the facility.
What this service includes
- Quality Manual & Governance Framework – Establish the quality policy, organisational responsibilities, quality objectives and overall framework governing the pharmaceutical quality system.
- SOP & Documentation Development – Develop controlled SOPs, work instructions, specifications, registers, standard forms, protocols and records covering critical operational and quality activities.
- Document & Record Control – Establish systems for document creation, review, approval, issuance, revision, archival and retention to maintain complete control and traceability of GMP documentation.
- Deviation, CAPA & Investigation Systems – Establish procedures for recording and investigating deviations, identifying root causes and implementing corrective and preventive actions.
- Change Control – Develop structured processes for assessing, approving, implementing and documenting changes that may affect product quality, validated systems or regulatory compliance.
- Training & Personnel Qualification – Establish role-based training requirements, training records, competency assessments and systems for maintaining personnel qualification.
- Risk Management – Implement quality risk management principles to identify, assess and control risks to product quality, patient safety and regulatory compliance.
- Supplier & Material Quality Management – Establish systems for supplier qualification, material approval, specifications, incoming controls and ongoing supplier performance monitoring.
- Complaints, Returns & Recall Systems – Develop procedures for managing product complaints, returned products and recalls, including investigation, documentation and escalation requirements.
- Self-Inspection & Quality Review – Establish internal audit, quality review and performance monitoring processes to identify compliance gaps and drive continual improvement.
Quality systems designed to work in practice
An effective QMS should do more than satisfy an auditor. It should provide the structure required to consistently control operations, investigate problems, manage change and demonstrate that products are manufactured under controlled conditions. We develop quality systems around the actual activities, personnel and risks within each facility rather than relying on generic documentation templates. By integrating quality requirements into everyday operations, we help facilities establish a QMS that is practical for personnel to use, scalable as the business develops and capable of supporting long-term EU GMP compliance.
Ready to build a compliant, profitable cannabis facility?
Whether you're developing a new facility or improving an existing operation, we can help you build the systems, capabilities and compliance required for long-term commercial success.