Quality Assurance & Audits
Quality is an essential basic requirement in order to maintain
the reliability at every stage of the development process.
Quality assurance is one subject that is complex and confusing to many clients who are applying to become Licensed Producers, whether beginners or those already established in the medicinal cannabis industry under the ACMPR program.
Cannabis Compliance Inc., believes high level of quality is essential to achieve not only Company’s business objectives but also client satisfaction. Quality, a source of competitive advantage, remains hallmark of Company services. High quality, a multi fold activity, is not an added value; it is an essential basic requirement to maintain the reliability at every stage of development process starting from research, clinical studies, manufacturing, laboratory testing, quality control, distribution and marketing to giving the confidence to client for Health Canada Audit preparation and compliance. Cannabis Compliance Inc.’s quality system in a nutshell can be defined as processes, procedures and resources for implementing quality management by believing that quality is a culture followed through dedication and integrity as safety of consumer product is our number one priority. We help our clients to prepare for Health Canada Audits by pre -inspecting the sites and making sure the facility is ready to be inspected and in compliance with the regulations. Therefore, our quality system is an integrated program taking into account the principals of Good Production Practices (GPP), Hazard Analysis of Critical Control Points (HACCP) and combining the guidelines from:
- Good Manufacturing Practices Guidelines: GUI-0001
- The Canadian Food and Drug Act Regulations
- Pharmaceutical Quality/Manufacturing Standards (CGMP)
- Cleaning Validation Guidelines: GUIDE-0028
- Good Manufacturing Practices for Active Pharmaceutical Ingredients: GUI-0140
- Validation Guidelines for Pharmaceutical Dosage Forms: GUI-0029
Cannabis Compliance Inc., doesn’t stop at that, we also make sure that our quality systems are integrated with the other existing guidelines as below:
- Controlled Drugs and Substances Act (CDSA)
- Narcotic Control Regulations (NCR)
- ICH Q7: Good Manufacturing Practices for Active Pharmaceutical Ingredients
- ICH Q9: “Quality Risk Management”
- ICH Q10: Pharmaceutical Quality System
- ICH Q11: Development and Manufacturing of Drug Substances
- ACMPR: Access to Cannabis for Medical Purposes Regulation
- Pest Control Products Act/ Pest Management Regulatory Agency (PMRA)
Cannabis Compliance Inc. takes into account local, regional, national, and international legal, ethical and regulatory requirements. Medicinal marijuana needs to go through a series of compliance regulations to be legitimate as medicine. Patients need confidence in high-quality medicine, the medicines we buy in a pharmacy have been through constringent regulations to insure the quality. We at Cannabis compliance Inc., make sure to assist our clients in the strategic direction and development of Quality Systems with the knowledge of over-all compliance, internal and external quality auditing skills. We provide the client with our expertise in technical and regulatory services:
- Understanding of Facility System like Water system, HVAC system and etc.
- Pharmacopoeias: knowledge of analytical test methods
- Validation Approach & Auditing Techniques
- Understanding of Qualification of New Build, Equipment & Calibration
With the health of people in question we make quality and safety of our clients’ medicinal cannabis our number one priority. We firmly believe that PURITY, SAFETY and CONSISTENCY are three important things in determining quality of the medical cannabis.