As the growth of the cannabis and hemp industry continues to accelerate, regulations will play an increasingly crucial role toward the goal of ensuring safe and consistent products are delivered to consumers. Our regulatory licensing and compliance services can help you navigate the complex compliance pathway to meet standards and assurances on product quality, efficacy and safety.
Services and Solutions
Remediation
Our experts work with you to identify and address deficiencies at their root cause. We liaise directly with Health Canada on your behalf. We develop appropriate procedures, metrics and support continuous improvement towards sustainable compliance.
Post-Market Authorization
Partner with us across your entire product life cycle with our Quality Management System (QMS) Program. We work confidentially with you from your initial product research & development; to supporting your regulatory requirements (pre-market authorization, operational licenses, and GMP compliance), to Quality Control and Assurance (production, importation, distribution and post-market authorization).
Labeling and Packaging Review
Regulatory support services for labeling and packaging review and registration for new products to meet Health Canada’s regulatory requirements.
Licensing Support
We offer consulting services to obtain the following Health Canada licenses.
- Standard Cultivation & Micro-Cultivation
- Standard Processing & Micro-Processing
- Sale for Medical Purposes
- Analytical Testing
- Research
- Nursery
Training Programs
- Good Production Practices (GPP)
- Good Manufacturing Practices (GMP)
- Specifications Development
- Standard Operating Procedures (SOPs)
Validation Studies
Design and execution of Master Validation Plans for process, cleaning and analytical test methodology.
Onsite Laboratory Set-Up and Support
Perform quality analysis directly at your site with our laboratory set-up, operational guidance and execution services.
- Cannabis Edibles
- HACCP Certification
- SQF Certification
- BRC Certification
- GAP Analysis and Certification
- Preventative Control Plan
GMP Audits for Cannabis Producers: Ensuring Regulatory Compliance in Canada
As Health Canada tightens its regulatory expectations for cannabis production, Good Manufacturing Practices (GMP) audits have become an essential step for companies involved in the cultivation, processing, manufacturing, storage, and sale of cannabis products. Whether you’re looking to maintain your current licence or expand into international markets, GMP compliance is critical to your operational success.
Why Cannabis Firms Need GMP Audits
Health Canada mandates cannabis producers to meet stringent quality standards under the Cannabis Regulations, with increasing alignment to internationally recognized GMP frameworks such as EU-GMP and ICH Q7 for active pharmaceutical ingredients. GMP audits help:
- Identify gaps in your Quality Management System (QMS)
- Mitigate risks to product safety, identity, strength, purity, and quality
- Prepare for inspections by Health Canada or international regulators
- Support international export of cannabis for medical or pharmaceutical use
What a GMP Audit Covers
Our audit process assesses compliance across the full product lifecycle. Key areas include:
1. Cultivation & Harvesting
- Sanitation programs for grow rooms and equipment
- Pest control and contamination prevention
- Environmental monitoring and HVAC validation
2. Processing & Manufacturing
- Batch production records (BPRs) and standard operating procedures (SOPs)
- In-process controls for potency, microbial contamination, and residual solvents
- Qualification and validation of equipment, methods, and cleaning procedures
3. Storage & Distribution
- Temperature and humidity control for product stability
- Controlled access and security protocols
- Inventory tracking systems for lot traceability and recall readiness
4. Quality Control (QC) & Laboratory Testing
- Analytical method validation for THC/CBD content, contaminants, and foreign matter
- Data integrity and calibration logs
- Compliance with GLP and ISO/IEC 17025 (where applicable)
5. Documentation & QMS
- Deviation and CAPA (Corrective and Preventive Actions) procedures
- Change control and training records
- Annual Product Quality Reviews (APQR)
Canadian GMP Requirements: What Health Canada Expects
Under Part 5 of the Cannabis Regulations, licence holders must demonstrate robust GMP-aligned quality systems that ensure product safety and consistency. Health Canada expects:
- A qualified Quality Assurance Person (QAP) to oversee release decisions
- Documented risk-based approaches to manufacturing
- Validated processes for extraction, formulation, and packaging
- Timely reporting of adverse reactions and recalls
Cannabis products for export or pharmaceutical use must often meet EU-GMP or PIC/S standards, necessitating a higher level of compliance and international audit-readiness.
Get Audit-Ready with MCS Associates
At MCS Associates, we’ve supported dozens of Canadian cannabis firms in preparing for successful GMP audits. Our consultants bring deep regulatory expertise and hands-on industry experience to help you:
- Conduct internal GMP readiness assessments
- Implement remediation plans aligned with audit findings
- Train personnel on SOP compliance, CAPA, and documentation best practices
- Achieve certification for international market access
Is Your Facility Ready for a GMP Audit?
Whether you’re scaling operations or targeting new markets, GMP compliance is more than a checkbox—it’s your license to operate and grow. Let MCS Associates guide your team through the complexities of GMP audits with confidence.
Contact us today to schedule your cannabis GMP readiness consultation.