Quality Assurance & GMP

OUR QA PROCEDURES ASSURE YOUR COMPLIANCE

Our Quality Assurance (QA) controls and strict adherence to Health Canada Regulatory Protocols, combined with the flexibility to customize procedures to meet specific client requirements, is your assurance that GMP, regulatory compliance and industry best practices are being exceeded on your behalf.

Compliance

The Accuristix Quality Assurance team ensures a GMP-compliant environment for your products, utilizing:

Validated Quality Management System
Validation and preventative maintenance programs for all systems, areas and equipment
Continuous facility temperature monitoring with alert/alarm notifications
Deviation, CAPA and Change Control programs
Employee GMP, SOP and client manual training programs

Resources and Training

Accuristix has highly qualified and trained QA resources at all of our facilities with:

Experience in all GMP healthcare and regulatory requirements and in-depth knowledge of GUI-0069 compliance requirements
Dedicated management to host and support client and Health Canada audits
Product hold and recall capabilities
Inbound inspection and sampling programs

Validation

Accuristix facilities, equipment and systems are validated by our internal team to regulatory requirements. Our validation expertise can also support your needs for facilities, systems and equipment qualification.

Validation of facilities and storage areas to GMP and GUI-0069 requirements
Validation of Warehouse Management and other systems to meet governance and data integrity requirements
Equipment validation including performing IQ/OQ/PQ

Narcotics and Controlled Substances

Accuristix QA oversees the storage and distribution of all narcotics, controlled drug and precursor products to ensure regulatory compliance to all Health Canada protocols related to: