GMP Services
Qualification & Validation
Ensure your facilities, equipment, utilities, processes, and cleaning procedures are qualified and validated to demonstrate consistent performance and compliance with EU GMP requirements. We develop and execute risk-based qualification and validation protocols that provide confidence in product quality and regulatory readiness.
What this service includes
- Validation Master Planning – Develop validation strategies and master plans defining the scope, responsibilities, methodology and lifecycle approach for qualification and validation activities.
- User Requirements & Design Qualification (URS/DQ) – Define user requirements and review facility, utility, equipment and system designs to confirm they are suitable for their intended use and applicable GMP requirements.
- Installation Qualification (IQ) – Verify and document that equipment, utilities and critical systems have been installed correctly and in accordance with approved specifications and design requirements.
- Operational Qualification (OQ) – Challenge equipment and systems across defined operating ranges to demonstrate that they perform consistently according to predetermined requirements.
- Performance Qualification (PQ) – Demonstrate that equipment, utilities and systems perform effectively and reproducibly under routine operating conditions.
- Process Validation – Develop and execute validation protocols to demonstrate that critical production processes consistently achieve predetermined quality and performance requirements.
- Cleaning Validation – Establish risk-based cleaning validation programmes, acceptance criteria, sampling strategies and protocols to demonstrate effective and reproducible cleaning.
- Computerised System Validation (CSV) – Assess and validate GMP-relevant software and automated systems, including user requirements, access controls, audit trails, data integrity and system lifecycle documentation.
- Requalification & Continued Verification – Establish periodic review, requalification and ongoing verification requirements to ensure qualified systems remain in a controlled state throughout their lifecycle.
Documented evidence that your systems perform as intended
Qualification and validation provide documented evidence that critical facilities, equipment, utilities, systems and processes are capable of consistently performing as intended. We apply a risk-based lifecycle approach, beginning with clearly defined user requirements and continuing through design review, qualification, validation and ongoing verification. By integrating qualification activities with facility design, commissioning, maintenance, calibration and the Quality Management System, we help establish a defensible state of control that can be demonstrated during regulatory inspection.
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.