Quality, Environmental, Sustainability, Health & Safety Policy
Every Tri-Pac employee is committed and aligned to:
Customer Satisfaction - Deliver high-quality products and services that meet or exceed customer expectations by engaging with customers to understand their needs and continuously improve our offerings.
Regulatory Compliance - Strictly comply with all applicable laws, regulations, and standards related to quality, safety, and environmental performance, while maintaining certifications and adhering to Good Manufacturing Practices (GMP).
Health & Safety - Prioritize the health and safety of our employees, customers, and stakeholders by maintaining a safe working environment and preventing injury and ill health through proactive safety measures and risk assessments.
Continuous Improvement - Continuously improve the effectiveness of our Quality Management System through regular reviews and updates, and implement corrective and preventive actions to address any issues and prevent recurrence.
Employee Involvement and Engagement - Foster a culture of quality and safety among all employees through regular training and development, and encourage active participation in quality improvement initiatives.
Environmental Responsibility and Sustainability - Incorporate pollution prevention and safety measures in product design, process design, and plant operations, reduce waste, energy consumption, and emissions, promote recycling and reuse, and aim for net zero emissions by 2050.
Community Engagement - Support the health, education, and well-being of local communities by leading by example in responding to adversities, challenges, and promoting sustainability.
Quality Assurance
At Tri Pac, we offer comprehensive quality control services, seamlessly integrating customer quality systems into our operations.
Our Quality Assurance Systems Include:
-
Compliance/Certification: FDA 21CFR 210/211/820, cGMP, ISO 9001:2015, ISO 13485:2016, ISO 22716: 2007, UL GMP, Canada FDR, and ICH Guidelines
-
Protocols: Incoming, in-process, and final product release protocols.
-
Validated Systems: Production and laboratory systems validated and verified.
-
Technology Transfers: Validated and verified methods and technology transfers.
-
Documentation Control: Specification and documentation control with lot traceability record management.
-
Core Tools: eQMS, SAP B1 HANA ERP, LIMS, PFMEA, SPC, Vision Systems.
-
Audits and Corrective Actions: Ongoing audits and a closed-loop corrective action system.
-
Laboratory Facilities: Onsite wet chemistry laboratory facilities fully integrated with your testing requirements.
-
Microbial Analysis: Onsite microbial analysis for yeast, mold, and bacteria testing.
Focus on Regulatory Compliance:
-
Medical Devices: We ensure compliance with 21 CFR 820 Medical Device Regulations and are certified to ISO 13485: 2016
-
Over the Counter (OTC) Products: Our processes adhere to 21 CFR 210/211 FDA and Health Canada standards for drugs, ensuring safety, quality, and effectiveness and are certified to UL GMP 21 CFR 210/211 and UL Health Canada FDR Part C Division 2
-
Cosmetic Products: We comply with FDA and Health Canada regulations, including the Cosmetic Regulations under the Food and Drugs Act, ensuring all cosmetics are safe and meet regulatory requirements and are certified to ISO 9001:2015 and ISO 22716:2007
-
Tri Pac ensures efficient service, maximizing the value of your packaging investment. Each product's specifications are detailed in our Product Files (DMF, DHF, MDF, MPR, PCD), guiding your products from incoming quality inspection through formulation, manufacturing and release.
-
Our inspection process adheres to rigorous industry standards, ensuring precision at every stage of product development. Our plant operates under current Good Manufacturing Practices (cGMP) and complies with both local and international regulatory authorities and national compliance agencies.
Our Certifications
Highlights
Testing Systems
Calibrated & Qualfiied equipment
In-line Vision Systems & SPC
Wet Chemistry & Microbial Analysis
Part 11 Compliant LIMS
Process Checks
Process & Packaging Validation
Cleaning Validation
Product Analysis
Master Batch Records
Part 11 Compliant QMS
Compliance Controls
Quality Management System
Lab Information Management System
Environmental Management Systems
Regulatory & Legal
Analytical & R&D Labs
Calibrated & validated equipment
Qualified analysts-supervisor team