Quality Assurance & Compliance
Quality is the Foundation of Everything We Do
CPL’s commitment to quality is upheld by a dedicated team of 30+ quality assurance and 40+ quality control professionals. With on-site QA inspectors and a highly successful regulatory inspection history at our Danbro and Meadowpine campuses, we integrate our systems, robust processes, and a culture of excellence to ensure product integrity and compliance at every stage of every program.
Quality Assurance Enabled by Our Robust Quality System
Quality assurance at CPL is driven by our experienced teams and supported by robust, well-established quality systems. With a long track record of successful inspections by the US FDA, Health Canada, and other global regulators, our more than 30-person quality assurance team oversees incoming material inspection and release, specifications, test methods, work orders, and product investigations. Full-time quality inspectors are present on the production floor. At the same time, continuous training ensures personnel remain aligned with evolving regulations, best practices, and a culture of compliance from concept through commercial supply.
Data-Driven Quality Management System Supports Regulatory Excellence
Scalable Commercial Manufacturing Built on Quality and OTIF Delivery
Our technology-enabled Quality Management System (QMS) provides the structure needed to support the work and ensure the success of our highly experienced quality assurance and quality control teams. TrackWise Digital, an industry-leading quality ecosystem, enables centralized control of quality processes, including change control, deviations, CAPAs, and complaint investigations.
SAP complements this infrastructure by managing critical quality operations, from triggering sampling and testing to final material disposition. Together with our LIMS and document management systems, these digital tools ensure real-time oversight, traceability, and data integrity, driving operational efficiency and reinforcing our culture of quality across the enterprise.
Critical Licenses and Outstanding Inspection
Record Among Global Regulators
CPL holds the licenses necessary to manufacture a variety of complex, challenging-to-handle semi-solid and non-sterile liquid products, including controlled substances and natural health products. With a strong track record of regulatory success, our production and QC lab sites have consistently achieved compliant outcomes in inspections by Health Canada, the US FDA, and other leading global health authorities.
Key Licenses
GMP Production Site and Quality Control Laboratory Inspection History
Inspections by leading global regulatory bodies have consistently achieved compliant outcomes.
CPL Production Site
Danbro
Authority
Canada
2024
Compliant
USA
2023
Compliant
Brazil
2023
Compliant
Canada
2021
Compliant
Japan
2021
Compliant
Canada
2019
Compliant
USA
2017
Compliant
CPL QC Laboratory
Meadowpine
Authority
Canada
2026
Compliant
USA
2025
Compliant
Brazil
2025
Compliant
Canada
2021
Compliant
Japan
2021
Compliant
Canada
2019
Compliant
USA
2017
Compliant
Dedicated to Excellence
from Molecule to Commercialization
CPL supports programs from early-phase through commercial launch, combining preformulation insight, robust semi-solid and non-sterile liquid development, scalable process design, and clinical and commercial manufacturing.
Pharmaceutical Development Services
Pharmaceutical Development Services
Comprehensive expertise that turns molecules into scalable, compliant, market‑ready semi-solid and non-sterile therapies.
Analytical & Product Testing
Analytical & Product Testing
Robust analytics power confident development and manufacture of topical and non-sterile liquid products.
Clinical & Commercial Manufacturing
Clinical & Commercial Manufacturing
More than three decades of GMP manufacturing experience from clinical supply through commercialization.
Packaging, Labeling & Serialization
Packaging, Labeling & Serialization
Integrated packaging, serialization, and aggregation ensure compliant, continuous commercial supply.
Semi-Solid & Non-Sterile Liquid Expertise
Semi-Solid & Non-Sterile Liquid Expertise
Pure-play CDMO for semi-solids and non-sterile liquids, with advanced micro encapsulation capabilities.
Unique Product Handling Experience
Unique Product Handling Experience
Infrastructure and expertise to manage complex, higher-risk semi-solid and non-sterile liquid products.
FAQs
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Quality is embedded directly into CPL’s operations, not layered on afterward. Full‑time quality inspectors are present on the production floor, providing real‑time oversight, immediate issue escalation, and continuous compliance with cGMP requirements. This hands‑on approach helps prevent deviations before they occur and ensures consistent product quality.
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CPL operates a technology‑enabled quality system anchored by TrackWise Digital, SAP, a LIMS, and a comprehensive document management platform. TrackWise Digital manages deviations, change control, CAPAs, and complaint investigations, while SAP supports material sampling, testing workflows, and final disposition, ensuring traceability, data integrity, and audit readiness.
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All raw materials and packaging components undergo incoming inspection, sampling, and formal QA release before use. Finished products are tested against approved specifications using validated methods, with all results reviewed by Quality Assurance before release. These controls support consistent compliance with FDA, Health Canada, and global regulatory expectations.
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CPL has a long history of successful, compliant inspections by global regulatory agencies, including the US FDA, Health Canada, PMDA (Japan), and ANVISA (Brazil). Both manufacturing and quality control sites consistently demonstrate inspection readiness, reflecting CPL’s strong quality culture, systems, and experienced QA/QC teams.
Commitment.
Partnership. Legacy.
Leverage CPL’s 35 years of expertise in non-sterile liquids and semi-solids to ensure your program's success. We’ll support your product from molecule to market, or step in at any stage of its product lifecycle.
