Ensure your compounding operations remain safe, compliant, and reliable with a full suite of laboratory testing and environmental monitoring services designed specifically for compounding pharmacies. Innovotech is a proudly Canadian, GMP-accredited laboratory with over 20 years of experience, offering comprehensive testing solutions to support compliance with USP <797>, USP <800>, the National Association of Pharmacy Regulatory Authorities (NAPRA), and Health Canada.
A regular monitoring program is a key component of a strong quality system. Our services help you maintain effective control over personnel, facilities, and equipment while identifying microbial risks early—allowing you to take timely action and safeguard the integrity of your operations.
NAPRA (National Association of Pharmacy Regulatory Authorities) sets the standards for non-sterile and sterile compounding in Canada. These standards outline environmental monitoring, personnel qualification, and product testing requirements to ensure patient safety and product quality. NAPRA testing verifies that compounding pharmacies meet these regulatory expectations, including microbial control, cleanroom performance, and process validation.
Independent laboratory testing provides objective, defensible data that demonstrates compliance with regulatory standards such as NAPRA and USP requirements. Third-party testing strengthens quality assurance programs, supports inspection readiness, and ensures compounded preparations meet required safety and quality standards before reaching patients.
Innovotech supports sterile compounding pharmacies through validated sterility testing, endotoxin testing, environmental monitoring programs, and microbial identification services. Our laboratory operates under a robust quality management system to ensure reliable, audit-ready data. We also assist with interpreting results, trending environmental data, and supporting corrective actions when required.
Hazardous drug (HD) testing evaluates whether trace amounts of cytotoxic or other hazardous compounds are present on surfaces within a compounding environment. Pharmacies that prepare hazardous drugs must demonstrate that containment controls, cleaning procedures, and engineering controls are effective in preventing cross-contamination and protecting personnel. Surface sampling and analytical testing provide objective evidence that decontamination and cleaning protocols are working as intended and support compliance with NAPRA and USP <800> guidelines.
If testing results exceed action limits or specifications, Innovotech provides prompt notification and detailed reporting. Our team supports pharmacies with microbial identification, data interpretation, and technical insight to assist with root cause investigations and corrective and preventive actions (CAPA). Our goal is to help pharmacies quickly address issues, restore compliance, and maintain patient safety.
